Class II FDA device recall · Z-0580-2026

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM, Model Number: 6068093. 4. SPACER 6068096 CATALYFT PL LONG 9MM, Model Number: 6068096. 5. SPACER 6068113 CATALYFT PL SHORT 11MM, Model Number: 6068113. 6. SPACER 6068116 CATALYFT PL LONG 11MM, Model Number: 6068116. 7. SPACER 6069073 CATALYFT PL40 SHORT 7MM, Model Number: 6069073. 8. SPACER 6069076 CATALYFT PL40 LONG 7MM, Model Number: 6069076. 9. SPACER 6069093 CATALYFT PL40 SHORT 9MM, Model Number: 6069093. 10. SPACER 6069096 CATALYFT PL40 LONG 9MM, Model Number: 6069096. 11. SPACER 6069113 CATALYFT PL40 SHORT 11MM, Model Number: 6069113. 12. SPACER 6069116 CATALYFT PL40 LONG 11MM, Model Number: 6069116. 13. CATALYFT PL IMPLANT SET, Model Number: SPS03143. 14. CATALYFT PL 40 IMPLANT SET, Model Number: SPS03144. 15. KIT CATALYFT PL IMPLANTS, Model Number: SPS04012. 16. KIT CATALYFT PL 40 IMPLANTS, Model Number: SPS04013. 17. CATALYFT PL 40 IMP KIT, Model Number: SPSJEP40. 18. CATALYFT PL 40 HIGH IMP KIT, Model Number: SPSJEP4H. 19. CATALYFT PL 40 SHORT IMP KIT, Model Number: SPSJEP4S. 20. CATALYFT PL 40 SHORT HIGH IMP KIT, Model Number: SPSJEP4T. 21. CATALYFT PL STRAIGHT HIGH IMP KIT, Model Number: SPSJEPSH. 22. CATALYFT PL STRAIGHT IMP KIT, Model Number: SPSJEPSI. These systems utilize the following affected Instructions for Use (IFU), Document M333023W048E, and Surgical Technique Guide, Document M333023W217.

Why it was recalled

Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

IFU: M333023W048E Rev. A  Surgical TechniqueM333023W217, Rev. 2.0    1. Model Number: 6068073. GTIN (Lot Numbers): 00763000246693 (0835083W, 0836192W, 0837725W, 0837727W, 0839577W, 0839579W, 0839591W, 0839593W, 0839595W, 0841459W, 0842257W, 0842767W, 0842769W, 0845001W, 0845003W, 0846533W, 0849546W, 0849548W, 0849998W, 0854451W, 0856696W, 0856698W, 0858703W, 0868179W, 0868231W, 0869637W, 0869695W, 0872240W, 0873202W, 0874502W, 0874504W, 0877435W, 0878670W, 0879342W, 0879887W, 0881316W, 0885958W, 0885960W, 0886068W, 0886070W, 0887342W, 0888799W, 0889934W, 0889936W, 0891419W, 0891951W, 0893270W, 0893332W, 0894905W, 0896952W, 0896954W, 0897308W, 0900773W, 0900970W, 0901192W, 0902362W, 0903362W, 0904350W, 0906154W, 0907656W, 0908818W, 0908820W, 0910150W, 0910202W, 0914572W, 0914574W, 0914576W, 0914578W, 0914580W, 0917478W, 0917480W, 0917662W, 0918071W, 0918073W, 0918075W, 0918077W, 0918858W, 0918860W, 0918862W, 0918864W, 0918866W, 0918886W, 0918888W, 0922033W, 0924471W, 0925397W, 0926139W, 0926361W, 0927266W, 0931914W, 0931916W, 0933069W, 0933071W, 0933073W, 0933075W, 0934823W, 0934825W, 0934827W, 0934998W, 0935000W, 0936452W, 0936454W, 0936456W, 0936458W, 0937870W, 0937872W, 0939113W, 0939115W, 0939324W, 0939326W, 0941080W, 0941364W, 0941366W, 0941912W, 0941914W, 0942912W, 0943255W, 0943257W, 0943953W, 0943955W, 0943957W, 0945701W, 0945946W, 0945948W, 0945950W, 0950146W, 0950148W, 0950150W, 0951512W, 0951514W, 0951516W, 0952750W, 0952752W, 0954062W, 0954064W, 0954430W, 0955352W, 0955892W, 0955894W, 0957547W, 0957549W, 0957551W, 0958456W, 0958458W, 0958460W, 0958854W, 0958856W, 0958858W, 0958860W, 0959360W, 0959425W, 0959427W, 0959429W, 0959431W, 0959433W, 0960482W, 0960484W, 0960486W, 0960488W, 0960490W, 0960492W, 0960494W, 0960496W, 0960498W, 0965510W, 0965512W, 0965514W, 0967296W, 0967298W, 0967300W, 0969065W, 0973081W, 0973083W, 0973837W, 0973839W, 0976737W, 0976739W, 0977571W, 0977573W, 0978651W, 0978653W, 0980738W, 0980740W, 0980752W, 0980754W, 0980756W, 0982541W, 0982543W, 0983620W, 0983622W, 0985251W, 0985253W, 0985576W, 0985580W, 0985582W, 0985584W, 0985586W, 0986386W, 0986388W, 0990940W, 0990959W, 0990962W, 0990964W, 0993272W, 0998279W, 0999003W, 0999209W, 0999869W, 0999908W, 1000718W, 1000720W, 1002203W, 1002205W, 1002207W, 1002209W, 1002341W, 1002343W, 1002445W, 1002447W, 1002449W, 1002453W, 1003053W, 1003055W, 1003057W, 1003059W, 1003061W, 1003064W, 1003066W, 1003068W, 1003590W, 1004007W, 1005087W, 1005089W, 1005091W, 1005093W, 1005095W, 1005097W, 1005099W, 1005113W, 1005115W, 1005117W, 1005119W, 1005681W, 1005683W, 1006066W, 1006068W, 1006608W, 1006610W, 1007433W, 1007435W, 1007439W, 1007561W, 1007563W, 1007565W, 1007567W, 1007569W, 1007571W, 1008244W, 1008246W, 1008248W, 1008250W, 1008572W, 1008574W, 1008578W, 1008580W, 1008905W, 1008907W, 1008909W, 1009421W, 1009423W, 1009425W, 1009427W, 1009429W, 1009431W, 1009433W, 1009435W, 1010466W, 1010468W, 1010470W, 1010542W, 1010544W, 1010546W, 1010548W, 1010550W, 1010552W, 1010554W, 1012752W, 1012754W, 1013081W, 1013085W, 1014062W, 1014064W, 1014852W, 1014854W, 1015300W, 1015562W, 1015564W, 1016350W, 1016352W, 1016354W, 1016356W, 1016358W, 1017284W, 1017286W, 1017288W, 1017290W, 1017292W, 1017294W, 1017296W, 1018228W, 1018232W, 1018234W, 1018236W, 1018324W, 1018326W, 1018652W, 1018654W, 1018656W, 1018658W, 1018660W, 1018662W, 1019499W, 1020114W, 1020116W, 1020118W, 1020120W, 1020202W, 1020204W, 1020206W, 1020513W, 1020515W, 1020517W, 1021425W, 1021729W, 1021761W, 1021763W, 1021765W, 1021767W, 1023316W, 1024125W, 1024127W, 1024129W, 1024213W, 1024215W, 1024217W, 1024221W, 1025110W, 1025154W, 1025156W, 1025158W, 1025160W, 1026564W, 1026566W, 1026568W, 1026570W, 1026823W, 1026825W, 1026827W, 1027612W, 1028469W, 1028541W, 1028545W, 1028547W, 1028549W, 1028704W, 1028706W, 1030249W, 1033162W, 1033932W, 1034564W, 1034566W, 1034568W, 1034570W, 1035135W, 1035137W, 1035139W, 1035141W, 1035145W, 1035149W, 1035151W, 1035153W, 1035155W, 1035157W, 1035159W, 1035161W, 1036540W, 1036542W, 1036544W, 1036778W, 1036782W, 1036784W, 1036786W, 1037691W, 1037693W, 1037695W, 1038202W, 1038204W, 1038206W, 1038210W, 1038212W, 1038214W, 1038248W, 1038250W, 1039194W, 1039592W, 1039594W, 1039790W, 1040453W, 1040455W, 1040459W, 1040466W, 1040468W, 1040631W, 1040940W, 1041117W, 1041119W, 1041292W, 1041294W, 1041296W, 1041298W, 1041973W, 1042951W, 1042953W, 1042955W, 1042959W, 1042961W, 1042963W, 1042965W, 1042967W, 1042969W, 1043672W, 1043674W, 1043676W, 1043678W, 1044340W, 1044583W, 1044585W, 1044587W, 1044589W, 1044625W, 1044641W, 1044715W, 1044717W, 1044719W, 1045694W, 1046302W, 1046304W, 1046306W, 1046992W, 1046994W, 1047392W, 1047394W, 1047617W, 1047619W, 1048281W, 1048283W, 1048285W, 1048287W, 1048289W, 1048291W, 1048293W, 1048882W, 1048884W, 1048886W, 1048888W, 1049712W, 1049714W, 1049716W, 1050572W, 1050574W, 1050576W, 1050578W, 1050580W, 1050582W, 1050584W, 1050586W, 1050588W, 1050590W, 1050592W, 1051163W, 1051165W, 1051167W, 1051630W, 1052418W, 1052420W, 1053318W, 1055497W, 1055499W, 1055561W, 1055563W, 1055565W, 1056843W, 1056845W, 1056847W, 1056849W, 1057482W, 1057484W, 1057486W, 1057994W, 1057996W, 1057998W, 1058000W, 1058102W, 1058104W, 1058106W, 1058108W, 1059122W, 1059124W, 1059126W, 1059128W, 1059673W, 1059675W, 1059677W, 1059679W, 1059681W, 1059685W, 1060016W, 1060018W, 1060042W, 1061130W, 1061132W, 1061134W, 1061136W, 1061138W, 1061140W, 1062398W, 1062400W, 1062402W, 1062404W, 1062406W, 1062410W, 1062412W, 1062414W, 1062418W, 1063591W, 1063593W, 1063595W, 1063597W, 1063599W, 1063601W, 1063603W, 1063605W, 1064184W, 1064186W, 1064188W, 1064190W, 1064192W, 1064194W, 1064196W, 1064198W, 1064688W, 1064690W, 1064935W, 1064937W, 1064939W, 1065454W, 1065456W, 1065458W, 1065460W, 1065472W, 1065474W, 1065476W, 1065882W, 1065884W, 1066272W, 1066274W, 1066469W, 1067027W, 1067029W, 1067031W, 1067033W, 1067035W, 1067037W, 1067039W, 1067721W, 1067723W, 1067725W, 1068010W, 1068312W, 1068314W, 1068316W, 1068318W, 1068320W, 1068322W, 1068324W, 1069172W, 1069174W, 1069176W, 1069178W, 1069679W, 1069683W, 1069685W, 1069687W, 1069689W, 1069691W, 1069693W, 1069697W, 1069699W, 1070304W, 1070308W, 1070310W, 1070405W, 1070407W, 1070409W, 1071241W, 1071243W, 1071245W, 1071247W, 1071249W, 1071251W, 1071253W, 1071255W, 1071257W, 1071259W, 1071476W, 1071478W, 1072574W, 1072580W, 1072582W, H5949771, H5958086, H5960046, H5960960, H5962266, H5962482, H5963060, H5966757, H5966776, H5967705, H5968960, H5969220, H5969817, H5975991, H5979175, H5979177, H5980995, H5981839, H5983795, H5984549, H5990897, H5991698, H5993288, H5995524, H5996143, H5996159, H5996493, H5996497, H5998670, H6000399, H6004407, H6009899, H6010724, H6010732, H6013796, H6014111, H6014312, H6014313, H6014549, H6014720, H6015908, H6018002, H6018003, H6018630, H6018659, H6018660, H6018663, H6018664, H6018668, H6020623, H6023750, H6023890, H6024117, H6024652, H6030042, H6032572, H6032577, H6040357, H6041546, H6048295, H6048303, H6060354, H6060358, H6060602, H6060606, H6062043); 00763000529567 (0856698W, 0858703W, 0868179W, 0868231W, 0869637W, 0869695W, 0872240W, 0885958W, 0886068W, 0889936W, 0894905W, 0900970W, 0901192W, 0908818W, 0910150W, 0910202W, 0914572W, 0914574W, 0914576W, 0914580W, 0917478W, 0917480W, 0918071W, 0918073W, 0918075W, 0918077W, 0918858W, 0918862W, 0918866W, 0918886W, 0922033W, 0924471W, 0931914W, 0931916W, 0933073W, 0933075W, 0934823W, 0934827W, 0934998W, 0935000W, 0936452W, 0936454W, 0936458W, 0937870W, 0937872W, 0939113W, 0939115W, 0939324W, 0939326W, 0941080W, 0941364W, 0941366W, 0941912W, 0941914W, 0942912W, 0943257W, 0943953W, 0943955W, 0945701W, 0945946W, 0945948W, 0945950W, 0950146W, 0950148W, 0950150W, 0951512W, 0952750W, 0952752W, 0954062W, 0954064W, 0954430W, 0955352W, 0955892W, 0955894W, 0957547W, 0957549W, 0957551W, 0958856W, 0958858W, 0958860W, 0959360W, 0959431W, 0960482W, 0960484W, 0960488W, 0960490W, 0960496W, 0965514W, 0967296W, 0973081W, 0973083W, 0973839W, 0977573W, 0978651W, 0980738W, 0980740W, 0980756W, 0982543W, 0983620W, 0985251W, 0985253W, 0985576W, 0985580W, 0986386W, 0986388W, 0990962W, 0990964W, 0998279W, 0999003W, 0999209W, 1000720W, 1002203W, 1002209W, 1003055W, 1003059W, 1003061W, 1003068W, 1003590W, 1004007W, 1005095W, 1006066W, 1006608W, 1007435W, 1007561W, 1007567W, 1007569W, 1008574W, 1008578W, 1008907W, 1008909W, 1009421W, 1009425W, 1009431W, 1010466W, 1010542W, 1010550W, 1010552W, 1012752W, 1013085W, 1016350W, 1016356W, 1017284W, 1017288W, 1017294W, 1018228W, 1018232W, 1018236W, 1018324W, 1018326W, 1018658W, 1019499W, 1020114W, 1020116W, 1020120W, 1020513W, 1021729W, 1021767W, 1023316W, 1024213W, 1024215W, 1024217W, 1025154W, 1025160W, 1026564W, 1026570W, 1026825W, 1027612W, 1028545W, 1028547W, 1028704W, 1034570W, 1035141W, 1035145W, 1035149W, 1035151W, 1035155W, 1035157W, 1035159W, 1035161W, 1036542W, 1037691W, 1037693W, 1038210W, 1038250W, 1039194W, 1039592W, 1040466W, 1040468W, 1042955W, 1042959W, 1042963W, 1043672W, 1043676W, 1044340W, 1044589W, 1044641W, 1044717W, 1045694W, 1046302W, 1046304W, 1046306W, 1047619W, 1048281W, 1048283W, 1048285W, 1048289W, 1048291W, 1048293W, 1048882W, 1050572W, 1050574W, 1050576W, 1050578W, 1050580W, 1050584W, 1050586W, 1050590W, 1050592W, 1052420W, 1056849W, 1057484W, 1057486W, 1059122W, 1059124W, 1059126W, 1059128W, 1059673W, 1059679W, 1059681W, 1060018W, 1060042W, 1061132W, 1061136W, 1061138W, 1061140W, H5962482, H5969220, H5979175, H5979177, H5980995, H5981839, H5983795, H5991698, H5993288, H6018660, H6024652, H6030042, H6032572, H6040357, 1002451W, 1008576W, 1040457W, 1056901W, H6028216).  2. Model Number: 6068076. GTIN (Lot Numbers): 00763000246709 (0831754W, 0836194W, 0836196W, 0837729W, 0842801W, 0844113W, 0848626W, 0851984W, 0852133W, 0852135W, 0854453W, 0855324W, 0858930W, 0860486W, 0862453W, 0869639W, 0869697W, 0870551W, 0873204W, 0873206W, 0874508W, 0877437W, 0879344W, 0879346W, 0879889W, 0881318W, 0881320W, 0881322W, 0881324W, 0888801W, 0891953W, 0891955W, 0891957W, 0891959W, 0891961W, 0893334W, 0895572W, 0896956W, 0896958W, 0897310W, 0900775W, 0901194W, 0902364W, 0903364W, 0904722W, 0906156W, 0907658W, 0910204W, 0910206W, 0914582W, 0917664W, 0920057W, 0920059W, 0922963W, 0924473W, 0928840W, 0929162W, 0931918W, 0933077W, 0933079W, 0933081W, 0935292W, 0935294W, 0936460W, 0937874W, 0939328W, 0940207W, 0940209W, 0941916W, 0943259W, 0943491W, 0943959W, 0947406W, 0948522W, 0948524W, 0951518W, 0952754W, 0952756W, 0954066W, 0954068W, 0955354W, 0955356W, 0955504W, 0955506W, 0957553W, 0957555W, 0959042W, 0959044W, 0961522W, 0962116W, 0962118W, 0962120W, 0962772W, 0962774W, 0967197W, 0967199W, 0967201W, 0969067W, 0973085W, 0974331W, 0974333W, 0975730W, 0976604W, 0976606W, 0976608W, 0976610W, 0976742W, 0978655W, 0978657W, 0980758W, 0980760W, 0980762W, 0983624W, 0986390W, 0989391W, 0992001W, 0992003W, 0992005W, 0992007W, 0992009W, 0993274W, 0993628W, 0993630W, 0995670W, 1002345W, 1002455W, 1002457W, 1003070W, 1003602W, 1004292W, 1004294W, 1004648W, 1004650W, 1005202W, 1007162W, 1007164W, 1007166W, 1007168W, 1007170W, 1007172W, 1007174W, 1007573W, 1007575W, 1007577W, 1007579W, 1007581W, 1007583W, 1010252W, 1010254W, 1010256W, 1010258W, 1010260W, 1010262W, 1010264W, 1010729W, 1011392W, 1011394W, 1011396W, 1011904W, 1011906W, 1013087W, 1013089W, 1013091W, 1013093W, 1013095W, 1013097W, 1013099W, 1014066W, 1014068W, 1014070W, 1014072W, 1014074W, 1014856W, 1014858W, 1014860W, 1015566W, 1015568W, 1015570W, 1015572W, 1015574W, 1015576W, 1015578W, 1016360W, 1018664W, 1018666W, 1019189W, 1019441W, 1019443W, 1019445W, 1019447W, 1019449W, 1020208W, 1020210W, 1020212W, 1020214W, 1020216W, 1020218W, 1021427W, 1021429W, 1021471W, 1021473W, 1021475W, 1021769W, 1022752W, 1024223W, 1025162W, 1026251W, 1026829W, 1027614W, 1027616W, 1027618W, 1027620W, 1028551W, 1030261W, 1031319W, 1031331W, 1031333W, 1031496W, 1031498W, 1031500W, 1031682W, 1032064W, 1032066W, 1032068W, 1032581W, 1032583W, 1032585W, 1033164W, 1033166W, 1033168W, 1033170W, 1033172W, 1033934W, 1034572W, 1034574W, 1034576W, 1034578W, 1034582W, 1034584W, 1036020W, 1036532W, 1036534W, 1036536W, 1036538W, 1036794W, 1036796W, 1036798W, 1036802W, 1041975W, 1041977W, 1041979W, 1042971W, 1043680W, 1043682W, 1043684W, 1043686W, 1043688W, 1043690W, 1044354W, 1044356W, 1044627W, 1044629W, 1044643W, 1044645W, 1044721W, 1045201W, 1045203W, 1045205W, 1045700W, 1045712W, 1045714W, 1046308W, 1046310W, 1046312W, 1046996W, 1046998W, 1047000W, 1047396W, 1047398W, 1048890W, 1048892W, 1054738W, 1054740W, 1054770W, 1054872W, 1054874W, 1055567W, 1055569W, 1055571W, 1055853W, 1055855W, 1055857W, 1056542W, 1056544W, 1056546W, 1057084W, 1057490W, 1057492W, 1057494W, 1058110W, 1067041W, H5949120, H5949481, H5953772, H5954271, H5960967, H5964111, H5964372, H5964627, H5965830, H5966104, H5968010, H5975985, H5976387, H5976389, H5976812, H5977791, H5979732, H5981967, H5982401, H5985530, H5985535, H5989329, H5990892, H5992876, H5993340, H5993606, H5994388, H5994451, H5997294, H5997295, H5997889, H5998255, H5998673, H5999512, H6000387, H6003392, H6003398, H6003403, H6004897, H6013456, H6015371, H6016681, H6020970, H6021535, H6023748, H6024154, H6024158, H6029815, H6029816, H6030132, H6030421, H6030423, H6030424, H6037256, H6040680, H6041095, H6046753, H6049447, H6049456, H6051115, H6051381, H6051486, H6051489, H6051620, H6051638, H6052354, H6054532, H6055364, H6059264, H6059280, H6060375, H6060376, H6061509, H6061801, H6061802, H6065331, H6065333, H6065334, H6066170, H6066171, H6066189, H6067518, H6067852, H6069509, H6069514, H6069738); 00763000529574 (0869639W, 0870551W, 0873204W, 0873206W, 0874508W, 0877437W, 0879344W, 0881320W, 0891957W, 0896958W, 0897310W, 0928840W, 0929162W, 0933077W, 0933079W, 0933081W, 0935292W, 0943959W, 0948522W, 0948524W, 0954066W, 0954068W, 0955354W, 0955356W, 0955504W, 0955506W, 0957553W, 0957555W, 0959042W, 0959044W, 0961522W, 0962120W, 0962774W, 0975730W, 0978655W, 0980758W, 0980762W, 0986390W, 0989391W, 0992003W, 0992009W, 0993274W, 1002455W, 1003070W, 1003602W, 1005202W, 1007162W, 1007172W, 1007174W, 1007573W, 1007577W, 1010256W, 1010262W, 1011394W, 1011906W, 1031333W, 1031496W, 1031500W, 1032066W, 1032068W, 1034572W, 1034584W, 1036020W, 1036534W, 1036798W, 1043684W, 1043686W, 1044354W, 1044645W, 1045712W, 1045714W, 1057492W, H5964111, H5964627, H5997294, H5997295, H5997889, H5998255, H5999512, H6016681, 0874506W).  3. Model Number: 6068093. GTIN (Lot Numbers): 00763000246723 (0831756W, 0837731W, 0839597W, 0842803W, 0844115W, 0846535W, 0847976W, 0849550W, 0850000W, 0850415W, 0850417W, 0850842W, 0862455W, 0865723W, 0868233W, 0868235W, 0869699W, 0870553W, 0870555W, 0870557W, 0871618W, 0874997W, 0874999W, 0877439W, 0879348W, 0879891W, 0881326W, 0881328W, 0881330W, 0889938W, 0891963W, 0893336W, 0893338W, 0893340W, 0895574W, 0895576W, 0896960W, 0898382W, 0900777W, 0901196W, 0902366W, 0903366W, 0904724W, 0906158W, 0907660W, 0910208W, 0910210W, 0914584W, 0914586W, 0917666W, 0920061W, 0920063W, 0922035W, 0922037W, 0922965W, 0924475W, 0929164W, 0929166W, 0931920W, 0933083W, 0936462W, 0936464W, 0936466W, 0939330W, 0940211W, 0940213W, 0944351W, 0947408W, 0948526W, 0950152W, 0951520W, 0952758W, 0952760W, 0954070W, 0954072W, 0955358W, 0955360W, 0955508W, 0957557W, 0957559W, 0959046W, 0959048W, 0959435W, 0959437W, 0961524W, 0967355W, 0967357W, 0967359W, 0969069W, 0973087W, 0974335W, 0974337W, 0976744W, 0976746W, 0978659W, 0980764W, 0980766W, 0980768W, 0980770W, 0982545W, 0983626W, 0983628W, 0983630W, 0984024W, 0987665W, 0987667W, 0992011W, 0992013W, 0993276W, 0999910W, 1002347W, 1002459W, 1002461W, 1002463W, 1002465W, 1003604W, 1003606W, 1004296W, 1005204W, 1008582W, 1008586W, 1008588W, 1008590W, 1008592W, 1008594W, 1008596W, 1010266W, 1010268W, 1010270W, 1010272W, 1010274W, 1010276W, 1010280W, 1011061W, 1011063W, 1011065W, 1011067W, 1011069W, 1011071W, 1011073W, 1013101W, 1013103W, 1014862W, 1014864W, 1014866W, 1014868W, 1016362W, 1020519W, 1020521W, 1021477W, 1021479W, 1021481W, 1021483W, 1021771W, 1021773W, 1021775W, 1023318W, 1023320W, 1023322W, 1023324W, 1023326W, 1024225W, 1024227W, 1024229W, 1024231W, 1024233W, 1024235W, 1024237W, 1025164W, 1025166W, 1025168W, 1025170W, 1025172W, 1026831W, 1026833W, 1026835W, 1033174W, 1033176W, 1033936W, 1033938W, 1033940W, 1033942W, 1033946W, 1033948W, 1035163W, 1035165W, 1035167W, 1035169W, 1035171W, 1036646W, 1036648W, 1036650W, 1036762W, 1036764W, 1038735W, 1051171W, 1051173W, 1051175W, 1051408W, 1051410W, 1051528W, 1051732W, 1051734W, 1051738W, 1052444W, 1052602W, 1052604W, 1053233W, 1053320W, 1054384W, 1054386W, 1054388W, 1054876W, 1054878W, 1054880W, 1054882W, 1054884W, 1055573W, 1055859W, 1056171W, 1061146W, 1062420W, 1062422W, 1062424W, 1062426W, 1063607W, 1063609W, 1063611W, 1063613W, 1063615W, 1063617W, 1063619W, 1064200W, 1064202W, 1064204W, 1064206W, 1064208W, 1064210W, 1064212W, 1065480W, 1065482W, 1065484W, 1065886W, 1065888W, 1066276W, 1067043W, 1067047W, 1067049W, 1067051W, 1067731W, 1067735W, 1068328W, 1069186W, 1070532W, H5967258, H5967772, H5969833, H5971306, H5974320, H5978126, H5979314, H5980562, H5985536, H5986047, H5989315, H5991474, H5993603, H5995533, H5996160, H5998668, H5998674, H5999515, H6000802, H6002928, H6005532, H6008224, H6008227, H6008684, H6008687, H6011078, H6017927, H6018624, H6021750, H6022943, H6023883, H6024773, H6024777, H6028242, H6028244, H6028247, H6030174, H6031557, H6031560, H6031562, H6036195, H6041821); 00763000529581 (0868233W, 0869699W, 0870553W, 0870555W, 0870557W, 0881326W, 0881328W, 0895574W, 0895576W, 0898382W, 0902366W, 0904724W, 0906158W, 0907660W, 0910210W, 0914586W, 0920061W, 0920063W, 0922035W, 0922037W, 0922965W, 0924475W, 0929166W, 0931920W, 0933083W, 0944351W, 0947408W, 0948526W, 0950152W, 0951520W, 0952758W, 0952760W, 0954070W, 0954072W, 0955358W, 0957559W, 0959046W, 0959048W, 0969069W, 0974335W, 0974337W, 0980766W, 0980770W, 0982545W, 0983626W, 0983628W, 0987665W, 0992011W, 0993276W, 1002459W, 1002461W, 1002463W, 1002465W, 1005204W, 1008582W, 1008586W, 1008590W, 1008594W, 1008596W, 1010272W, 1010276W, 1011065W, 1021481W, 1021483W, 1023318W, 1023326W, 1025164W, 1025166W, 1026835W, 1033176W, 1033938W, 1033940W, 1035171W, 1036764W, 1051408W, 1051410W, 1051738W, 1052604W, 1053233W, 1053320W, 1054386W, 1054388W, 1054878W, 1054880W, 1054882W, 1055573W, 1061146W, 1062422W, H5967258, H5974320, H5978126, H5980562, H5991474, H6000802, H6008687, H6021750, H6028244, H6031557, H6031562, 0871616W, 1033944W, 1052442W); N/A (1008592W).  4. Model Number: 6068096. GTIN (Lot Numbers): 00763000246730 (0831758W, 0836198W, 0836200W, 0836202W, 0837733W, 0842805W, 0844111W, 0848628W, 0849622W, 0852137W, 0852139W, 0854455W, 0855326W, 0860488W, 0860490W, 0862457W, 0864032W, 0864038W, 0871620W, 0872100W, 0873208W, 0881015W, 0881332W, 0885962W, 0885964W, 0887344W, 0887346W, 0887348W, 0888803W, 0889940W, 0891965W, 0893342W, 0893344W, 0898384W, 0900779W, 0901198W, 0901200W, 0902368W, 0903368W, 0904726W, 0906160W, 0907662W, 0910212W, 0910214W, 0914588W, 0914590W, 0917668W, 0920065W, 0920067W, 0924477W, 0929168W, 0929170W, 0931962W, 0935296W, 0935298W, 0935300W, 0936468W, 0937876W, 0937878W, 0939332W, 0940215W, 0940217W, 0942914W, 0943493W, 0945703W, 0947410W, 0948528W, 0950154W, 0951522W, 0952762W, 0952764W, 0954074W, 0954076W, 0955362W, 0955364W, 0955510W, 0957561W, 0957563W, 0959050W, 0959052W, 0959439W, 0959441W, 0959443W, 0961526W, 0961528W, 0967361W, 0968362W, 0968364W, 0968366W, 0969281W, 0973089W, 0974339W, 0974341W, 0976748W, 0977732W, 0986512W, 0987044W, 0987046W, 0987669W, 0988253W, 0988255W, 0988257W, 0989571W, 0989573W, 0990966W, 0992015W, 1002467W, 1002469W, 1002471W, 1002619W, 1003608W, 1003610W, 1003612W, 1003614W, 1004298W, 1004300W, 1004302W, 1004304W, 1004306W, 1004308W, 1004312W, 1004314W, 1005206W, 1005208W, 1006070W, 1006262W, 1007176W, 1007178W, 1007180W, 1007182W, 1007585W, 1007587W, 1007589W, 1007591W, 1007593W, 1007595W, 1007597W, 1007599W, 1007601W, 1009619W, 1010501W, 1010503W, 1010505W, 1010507W, 1011398W, 1011400W, 1011908W, 1011910W, 1012758W, 1013105W, 1016364W, 1016366W, 1016368W, 1016370W, 1016372W, 1016374W, 1016376W, 1017298W, 1017477W, 1017479W, 1017531W, 1017533W, 1017535W, 1017537W, 1017539W, 1018238W, 1018240W, 1018668W, 1018670W, 1018672W, 1018674W, 1018676W, 1018678W, 1018680W, 1018682W, 1019451W, 1019453W, 1019455W, 1020220W, 1020222W, 1020523W, 1020525W, 1021485W, 1021777W, 1022754W, 1022756W, 1022758W, 1022760W, 1023328W, 1023330W, 1024239W, 1024241W, 1024243W, 1026253W, 1031335W, 1031684W, 1031686W, 1031688W, 1032070W, 1032587W, 1032589W, 1033178W, 1033950W, 1034586W, 1035173W, 1036546W, 1036548W, 1036550W, 1036552W, 1037697W, 1037699W, 1037701W, 1037703W, 1037705W, 1037707W, 1037709W, 1037711W, 1038216W, 1038218W, 1038737W, 1039196W, 1039198W, 1047402W, 1047404W, 1048896W, 1048898W, 1048900W, 1049718W, 1049720W, 1049724W, 1049726W, 1049728W, 1049730W, 1049732W, 1049734W, 1050594W, 1050596W, 1050600W, 1051177W, 1051179W, 1058112W, 1058114W, 1058813W, 1058815W, 1058817W, 1059287W, 1059289W, 1060044W, 1060046W, 1060048W, 1060764W, 1060766W, 1060768W, 1060770W, 1060772W, 1067053W, 1067737W, 1068330W, 1068332W, H5956283, H5960953, H5964135, H5965898, H5966475, H5970317, H5970760, H5984641, H5989733, H5991687, H5991705, H5991988, H5993392, H5995463, H5998258, H5998282, H6004896, H6009876, H6010856, H6011481, H6012334, H6012339, H6012341, H6012342, H6015369, H6016337, H6021548, H6021637, H6021638, H6022792, H6037264, H6040370, H6044520, H6044521, H6046120, H6048318, H6049015, H6049835, H6049839, H6049845, H6051267, H6052448, H6053451, H6054112, H6055379, H6056422, H6056423, H6060611, H6066196, H6066198, H6067909, H6067910); 00763000529598(0862457W, 0864032W, 0864038W, 0871620W, 0872100W, 0873208W, 0881015W, 0898384W, 0902368W, 0903368W, 0935296W, 0935300W, 0937878W, 0939332W, 0943493W, 0951522W, 0952762W, 0952764W, 0954074W, 0954076W, 0955362W, 0955364W, 0957561W, 0959050W, 0959052W, 0959441W, 0973089W, 0988257W, 0989571W, 1003610W, 1003612W, 1007182W, 1050596W, 1051177W, 0864036W, 0873210W, 1004310W, 1007184W); N/A (1017479W).  5. Model Number: 6068113. GTIN (Lot Numbers): 00763000246754 (0831760W, 0836204W, 0837735W, 0839599W, 0841051W, 0842331W, 0844117W, 0846537W, 0847978W, 0849572W, 0849574W, 0868237W, 0870559W, 0874510W, 0879893W, 0885966W, 0887350W, 0888805W, 0896962W, 0898386W, 0900781W, 0901202W, 0902370W, 0903370W, 0905342W, 0910216W, 0922967W, 0924479W, 0927268W, 0929172W, 0939334W, 0951524W, 0952501W, 0952766W, 0954078W, 0957565W, 0957567W, 0961530W, 0962776W, 0968368W, 0969283W, 0973091W, 0976750W, 0977734W, 0995692W, 0997492W, 0997494W, 0997496W, 0999005W, 1000102W, 1002992W, 1006264W, 1031690W, 1032322W, 1032591W, 1033180W, 1033182W, 1033184W, 1033186W, 1033188W, 1033190W, 1033952W, 1033954W, 1041300W, 1041302W, 1041981W, 1041983W, 1041985W, 1041987W, 1042973W, 1042975W, 1042977W, 1042979W, 1043692W, 1050520W, 1051181W, 1052606W, 1052608W, 1064945W, 1064947W, 1067055W, 1067059W, H5959856, H5960023, H5976169, H5979255, H5980559, H5982391, H5995538, H5997547, H6018332, H6024477, H6030932, H6031564, H6035714, H6046424); 00763000529604 (0836204W, 0849572W, 0868237W, 0870559W, 0874510W, 0885966W, 0888805W, 0896962W, 0900781W, 0922967W, 0924479W, 0927268W, 0929172W, 0951524W, 0952766W, 0957565W, 0957567W, 0961530W, 0973091W, 0976750W, 1000102W, 1031690W, 1032591W, 1033954W, 1041300W, 1041981W, 1041983W, 1041987W, 1042977W, 1042979W, 1043692W, H5976169, H5980559, H5997547, 0854457W, 0857971W).   6. Model Number: 6068116. GTIN (Lot Numbers): 00763000246761 (0831762W, 0837093W, 0837737W, 0845005W, 0845007W, 0850844W, 0853143W, 0854459W, 0858932W, 0861112W, 0862459W, 0864040W, 0874512W, 0875981W, 0881017W, 0881334W, 0881336W, 0888807W, 0891967W, 0893346W, 0896964W, 0896966W, 0898388W, 0905344W, 0906452W, 0910218W, 0914592W, 0914594W, 0920069W, 0926363W, 0927270W, 0929174W, 0931964W, 0937880W, 0939336W, 0942916W, 0943495W, 0945705W, 0951526W, 0952503W, 0952768W, 0952770W, 0955366W, 0957569W, 0957571W, 0959054W, 0964248W, 0964250W, 0965516W, 0973093W, 0976752W, 0976754W, 0976756W, 0977736W, 0978661W, 0983632W, 0987048W, 0989575W, 0994928W, 0995694W, 1011075W, 1011402W, 1012052W, 1012054W, 1012056W, 1012058W, 1012760W, 1012762W, 1012764W, 1012766W, 1013107W, 1013109W, 1013111W, 1013113W, 1013115W, 1013117W, 1013119W, 1013121W, 1014076W, 1016378W, 1016380W, 1016382W, 1039200W, 1039202W, 1039822W, 1039824W, 1040470W, 1040492W, 1040633W, 1040635W, 1040637W, 1040639W, 1040641W, 1041304W, 1041306W, 1041308W, 1041989W, 1041991W, 1041993W, 1041995W, 1041997W, 1051522W, 1052610W, 1053235W, 1053237W, 1053239W, 1053342W, 1054390W, 1054392W, 1054394W, 1061148W, 1061150W, 1062428W, 1062430W, 1062432W, 1066280W, 1066282W, 1066284W, H5969398, H5972674, H5975979, H5976386, H5976707, H5979718, H5985104, H5991292, H5993488, H5996970, H6007862, H6011074, H6015364, H6022791, H6025215, H6025218, H6042906, H6043292, H6050290, H6051116, H6053616, H6055646); 00763000529611 (0874512W, 0875981W, 0881017W, 0881334W, 0881336W, 0891967W, 0898388W, 0905344W, 0929174W, 0952770W, 0957569W, 0957571W, 0959054W, 0964248W, 0965516W, 0977736W, 0987048W, 0989575W, 0994928W, 0995694W, 1013111W, 1039200W, 1053237W, 1054392W, 1061148W, H5972674, H5976707, H5985104, 0874514W).   7. Model Number: 6069073. GTIN (Lot Numbers): 00763000246785 (0831764W, 0837739W, 0837741W, 0839601W, 0839603W, 0842333W, 0849576W, 0853145W, 0854461W, 0855328W, 0857973W, 0858934W, 0862491W, 0865725W, 0874361W, 0875983W, 0877441W, 0879350W, 0879352W, 0885968W, 0887352W, 0888809W, 0889942W, 0891969W, 0896968W, 0898390W, 0900783W, 0901204W, 0901206W, 0902372W, 0903372W, 0905346W, 0907664W, 0917670W, 0917672W, 0918868W, 0918870W, 0918872W, 0918874W, 0920071W, 0920073W, 0922039W, 0922969W, 0924481W, 0939338W, 0942918W, 0943497W, 0943499W, 0945707W, 0951528W, 0952505W, 0952507W, 0952772W, 0952774W, 0955368W, 0957573W, 0960500W, 0962778W, 0962780W, 0964632W, 0965518W, 0968370W, 0969285W, 0969287W, 0976758W, 0977738W, 0978663W, 0978665W, 0983634W, 0989577W, 0989579W, 0992017W, 0993278W, 0993682W, 0994333W, 0994335W, 0994930W, 0995696W, 0999007W, 1003616W, 1003618W, 1004316W, 1004318W, 1004320W, 1007186W, 1007188W, 1009437W, 1009441W, 1009443W, 1009447W, 1009449W, 1009451W, 1009453W, 1011404W, 1011406W, 1011408W, 1011410W, 1011412W, 1011414W, 1011416W, 1012060W, 1012062W, 1012064W, 1017300W, 1017302W, 1017304W, 1017306W, 1017308W, 1017310W, 1017312W, 1018242W, 1018244W, 1018246W, 1018248W, 1018250W, 1019457W, 1019459W, 1019461W, 1019463W, 1019465W, 1019467W, 1019469W, 1035175W, 1036766W, 1036768W, 1036770W, 1036772W, 1036774W, 1036776W, 1037713W, 1037715W, 1038220W, 1038222W, 1038224W, 1038226W, 1038739W, 1038951W, 1038953W, 1038955W, 1039206W, 1039208W, 1039210W, 1039826W, 1039828W, 1039830W, 1040494W, 1040496W, 1040498W, 1040643W, 1040645W, 1040647W, 1040649W, 1048902W, 1048904W, 1048906W, 1049736W, 1049738W, 1049740W, 1049742W, 1049744W, 1050602W, 1050604W, 1050608W, 1050610W, 1050612W, 1050614W, 1051183W, 1051185W, 1051187W, 1051741W, 1051743W, 1057496W, 1058116W, 1058118W, 1058120W, 1058819W, 1058821W, 1058823W, 1058825W, 1058827W, 1058829W, 1059130W, 1060050W, 1060052W, 1060054W, 1060056W, 1060058W, 1060060W, 1060062W, 1064951W, 1065486W, 1065488W, 1065490W, 1065492W, 1065494W, 1065496W, 1065890W, 1065892W, 1065894W, 1066286W, 1066288W, 1067743W, 1067745W, 1067747W, 1067749W, 1071981W, 1071983W, 1071985W, 1071989W, H5960025, H5961680, H5962675, H5963063, H5964483, H5964903, H5966153, H5967526, H5974499, H5975996, H5976681, H5979308, H5984607, H5984805, H5985111, H5993303, H5995219, H5997146, H5997325, H6000119, H6009907, H6010342, H6010848, H6015956, H6015957, H6018341, H6018345, H6018346, H6018349, H6022886, H6022887, H6024860, H6024863, H6027581, H6028240, H6033629, H6036553, H6042589); 00763000868963 (0977738W, 0993682W, 0994335W, 0995696W, 0999007W, 1003618W, 1007186W, 1009443W, 1009447W, 1009449W, 1009453W, 1011410W, 1011412W, 1017306W, 1018242W, 1018250W, 1036774W, 1037713W, 1037715W, 1038220W, 1038224W, 1038226W, 1038739W, 1038953W, 1038955W, 1039206W, 1039208W, 1040496W, 1040498W, 1048904W, 1049736W, 1049738W, 1049740W, 1049742W, 1049744W, 1050608W, H5964903, H5966153, H5984805, H6000119, H6009907, H6010342, 1009439W, 1050606W).  8. Model Number: 6069076. GTIN (Lot Number): 00763000246792 (0831766W, 0836206W, 0837743W, 0839605W, 0839607W, 0842335W, 0842807W, 0854463W, 0856700W, 0857975W, 0861114W, 0862493W, 0865727W, 0869721W, 0870561W, 0870563W, 0870565W, 0875985W, 0881019W, 0885970W, 0885972W, 0887354W, 0887356W, 0895578W, 0896970W, 0898392W, 0900785W, 0903374W, 0905348W, 0906456W, 0907666W, 0910220W, 0910222W, 0914596W, 0914598W, 0917674W, 0918876W, 0918878W, 0920075W, 0926365W, 0926367W, 0927302W, 0931966W, 0935302W, 0935304W, 0937882W, 0937884W, 0939340W, 0942920W, 0947412W, 0947414W, 0948530W, 0950156W, 0951530W, 0954080W, 0957575W, 0959056W, 0959058W, 0959060W, 0960502W, 0960504W, 0965520W, 0969289W, 0973095W, 0974343W, 0976760W, 0976762W, 0977740W, 0982547W, 0982549W, 0995142W, 0995698W, 0997498W, 0997500W, 0997502W, 0998721W, 0999009W, 1000782W, 1000784W, 1002349W, 1002351W, 1002353W, 1002355W, 1002357W, 1005210W, 1006266W, 1007190W, 1009455W, 1009457W, 1009459W, 1012768W, 1012770W, 1012772W, 1014078W, 1014080W, 1014082W, 1014084W, 1014086W, 1014088W, 1024245W, 1024247W, 1024249W, 1025174W, 1025176W, 1025178W, 1025180W, 1025182W, 1025184W, 1026255W, 1026257W, 1026259W, 1026261W, 1030263W, 1032593W, 1032595W, 1033192W, 1040651W, 1040653W, 1040655W, 1041310W, 1041312W, 1041314W, 1041316W, 1041318W, 1041999W, 1042001W, 1042981W, 1042983W, 1042985W, 1042987W, 1042989W, 1042991W, 1042993W, 1043694W, 1043696W, 1051524W, 1051526W, 1053681W, 1053683W, 1054742W, 1054744W, 1054890W, 1054892W, 1056173W, 1056175W, 1056548W, 1056550W, 1056552W, 1057086W, 1057498W, 1057500W, 1057502W, 1058122W, 1058124W, 1063621W, 1063623W, 1064953W, 1064955W, 1064957W, 1064959W, 1064961W, 1067755W, 1067757W, H5956358, H5973087, H5975978, H5976695, H5977790, H5979741, H5980568, H5993941, H5995547, H5996600, H6002559, H6017939, H6018616, H6018617, H6018618, H6028231, H6030562, H6038010, H6038011, H6038861, H6038924, H6038927, H6041814, H6046740, H6046744, H6052034, H6052339, H6052342, H6052344, H6053190, H6054116, H6054120, H6055676, H6057303); 00763000529628 (0862493W, 0865727W, 0869721W, 0870561W, 0870563W, 0870565W, 0875985W, 0895578W, 0896970W, 0898392W, 0900785W, 0906456W, 0907666W, 0910220W, 0910222W, 0914596W, 0914598W, 0917674W, 0918876W, 0920075W, 0926365W, 0927302W, 0931966W, 0935304W, 0937882W, 0937884W, 0939340W, 0942920W, 0947412W, 0947414W, 0948530W, 0950156W, 0951530W, 0954080W, 0957575W, 0959056W, 0959058W, 0959060W, 0960502W, 0969289W, 0973095W, 0974343W, 0976760W, 0976762W, 0977740W, 0982547W, 0982549W, 0997498W, 0997500W, 0997502W, 0998721W, 0999009W, 1000782W, 1000784W, 1002349W, 1002351W, 1002353W, 1002355W, 1002357W, 1009459W, 1012772W, 1024249W, 1025176W, 1025178W, 1025182W, 1025184W, 1026257W, 1026259W, 1026261W, 1030263W, 1032593W, 1032595W, 1033192W, 1041310W, 1041316W, 1041318W, 1041999W, 1042001W, 1042991W, 1043694W, 1043696W, 1054742W, 1054744W, 1054890W, 1054892W, 1056548W, 1057498W, H5973087, H5975978, H5976695, H5977790, H5979741, H5980568, H6017939, H6018616, H6018617, H6018618, 0871642W, 0957577W, 1012774W, 1033194W, 1054888W).   9. Model Number: 6069093. GTIN (Lot Numbers): 00763000246815 (0835085W, 0836208W, 0839609W, 0841053W, 0842337W, 0844119W, 0847980W, 0848630W, 0854465W, 0857977W, 0858936W, 0861116W, 0864042W, 0864598W, 0865729W, 0868239W, 0868241W, 0868243W, 0870567W, 0874516W, 0877443W, 0885974W, 0887358W, 0887360W, 0896972W, 0898394W, 0901208W, 0905350W, 0906458W, 0910224W, 0910226W, 0918880W, 0918882W, 0920077W, 0922081W, 0923071W, 0924483W, 0951532W, 0952509W, 0954082W, 0957579W, 0957581W, 0961532W, 0962782W, 0964634W, 0969291W, 0977742W, 0977744W, 0978667W, 0982551W, 0995144W, 0995700W, 0997504W, 0998723W, 1000252W, 1005212W, 1011418W, 1012066W, 1012068W, 1012776W, 1012778W, 1014090W, 1014092W, 1014094W, 1014096W, 1014098W, 1014100W, 1023332W, 1023334W, 1024082W, 1027622W, 1027624W, 1027626W, 1027628W, 1027630W, 1028555W, 1028708W, 1028710W, 1028992W, 1028994W, 1029482W, 1029484W, 1030265W, 1031692W, 1043698W, 1043700W, 1044358W, 1044360W, 1044362W, 1044364W, 1044366W, 1045207W, 1051189W, 1060774W, 1060780W, 1060782W, 1061152W, 1061154W, 1061156W, 1061158W, 1062434W, 1062436W, 1062438W, 1063625W, 1063627W, 1063631W, 1063633W, 1064963W, 1064965W, 1064967W, 1065898W, 1065900W, 1066290W, 1068334W, 1073942W, H5960042, H5961689, H5967799, H5974501, H5974933, H5975083, H5979715, H5980972, H5991983, H5993359, H6000395, H6004895, H6010721, H6015923, H6020628, H6030549, H6031668, H6032600, H6034517

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide distribution - US Nationwide and Puerto Rico. The countries of Australia, Austria, Belgium, Canada, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Netherlands, New Caledonia, New Zealand, Norway, Portugal, Reunion, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

Recall record

Recalling firm: Medtronic Sofamor Danek USA Inc
Product type: Devices
Recall number: Z-0580-2026
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Memphis, TN
Recall initiated: 2025-09-16

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-0580-2026 · Source: openFDA enforcement.