FDA recall record · openFDA
Howmedica Osteonics Corp.
96 FDA recalls on record (2023–2026) — 96 device. 96 still ongoing.
0
Class I (most serious)
96
Class II
0
Class III
96
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. O 58
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell 12
Potential packaging breaches of inner blister and outer sterile blister. 8
Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the d 3
Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog 2
Recalls
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490 Class II 2026-02-02 The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infr Class II 2025-11-12 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0 Class II 2025-08-28 Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100 Class II 2024-08-05 TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Cata Class II 2024-02-27 TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalo Class II 2024-02-27 MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 Class II 2024-08-07 TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Class II 2024-02-27 TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Nu Class II 2024-02-27 TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalo Class II 2024-02-27 NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM Class II 2024-02-06 UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: Class II 2024-06-19 X3 TRIATHLON CS INSERT NO 6 10 MM Class II 2024-02-06 TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalo Class II 2024-02-27 UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: Class II 2024-06-19 Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910 Class II 2024-05-23 TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog N Class II 2024-02-27 Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications dur Class II 2024-09-04 TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Nu Class II 2024-02-27 UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: Class II 2024-06-19 X3 TRIATHLON CS INSERT NO 3 10 MM Class II 2024-02-06 HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900 Class II 2024-05-23 TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog N Class II 2024-02-27 TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Class II 2024-02-27 NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM Class II 2024-02-06 X3 TRIATHLON CS INSERT NO 7 9 MM Class II 2024-02-06 TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Class II 2024-02-27 X3 TRIATHLON CS INSERT NO 6 11 MM Class II 2024-02-06 NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM Class II 2024-02-06 TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Class II 2024-02-27 NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM Class II 2024-02-06 Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910 Class II 2023-12-01 PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031 Class II 2023-12-01 PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411 Class II 2023-12-01 SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110 Class II 2023-12-01 LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631 Class II 2023-12-01 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710 Class II 2023-12-01 SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910 Class II 2023-12-01 SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710 Class II 2023-12-01 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110 Class II 2023-12-01 DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911 Class II 2023-12-01 SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026 Class II 2023-12-01 stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty su Class II 2023-03-10 SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028 Class II 2023-12-01 SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032 Class II 2023-12-01 SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321 Class II 2023-12-01 TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E Class II 2023-04-13 LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028 Class II 2023-12-01 SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030 Class II 2023-12-01 DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609 Class II 2023-12-01 HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip art Class II 2023-12-22 HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J Class II 2023-12-01 SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710 Class II 2023-12-01 SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910 Class II 2023-12-01 DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611 Class II 2023-12-01 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308 Class II 2023-12-01 TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324 Class II 2023-12-01 PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416 Class II 2023-12-01 PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413 Class II 2023-12-01 SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514 Class II 2023-12-01 DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711 Class II 2023-12-01 HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J Class II 2023-12-01 TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E Class II 2023-04-13 P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107 Class II 2023-12-01 RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931 Class II 2023-12-01 SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524 Class II 2023-12-01 SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521 Class II 2023-12-01 LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228 Class II 2023-12-01 Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324 Class II 2023-12-01 LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328 Class II 2023-12-01 P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307 Class II 2023-12-01 SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110 Class II 2023-12-01 DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200 Class II 2023-12-01 SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512 Class II 2023-12-01 SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524 Class II 2023-12-01 RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928 Class II 2023-12-01 DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709 Class II 2023-12-01 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708 Class II 2023-12-01 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910 Class II 2023-12-01 Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910 Class II 2023-12-01 RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831 Class II 2023-12-01 LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231 Class II 2023-12-01 SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510 Class II 2023-12-01 SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515 Class II 2023-12-01 Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026 Class II 2023-05-03 HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip Class II 2023-12-22 stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty su Class II 2023-03-10 SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510 Class II 2023-12-01 Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908 Class II 2023-12-01 SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518 Class II 2023-12-01 SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516 Class II 2023-12-01 LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4-231 Class II 2023-12-01 HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J Class II 2023-12-01 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508 Class II 2023-12-01 Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908 Class II 2023-12-01 DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709 Class II 2023-12-01
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.