Class II FDA device recall · Z-0833-2024

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.

Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIP FRACTURE, kit number AHHF15D; c) Hand Pack, kit number BBHP10E; d) Lower Extremity, kit number BBLE40B; e) Custom Podiatry, kit number BOCP70J; f) ROBOTIC PACK, kit number BPAR65A; g) HIP PINNING PACK, kit number EMHP84; h) HIP PINNING PK, STRL F G, kit number FHHI17V; i) TOTAL HIP PACK, kit number GNTH06L; j) TOTAL KNEE PACK, kit number GNTK07L; k) EXTREMITY PACK, kit number GUEX48I; l) MAJOR ORTHO PACK, kit number GUMO40J; m) TOTAL KNEE ACCESS PACK, kit number HITK58D; n) SHOULDER ARTHROSCOPY, kit number HNSH17H; o) TOTAL HIP PACK, kit number HNTH76M; p) TOTAL KNEE PACK, kit number HNTK81M; q) ORIF HIP PACK, kit number HOHP28; r) DR. GREENWALD TOTAL KNEE, kit number HSGK80S; s) Custom Lower Ext, kit number JSLE08E; t) HAND PACK, kit number LVHD29; u) KIT, LOWER EXTREMITY, kit number MMEX19E; v) KIT, HIP PINNING, kit number MMHP45E; w) KIT, ORTHO SPINE, kit number MMSP21H; x) KIT, TOTAL HIP, kit number MMTH15E; y) KIT, TOTAL KNEE, kit number MMTK66E; z) KIT, UPPER EXTREMITY OPEN SHOULDER, kit number MMUE31E; aa) HIP SCOPE, kit number PTHS10D; bb) HIP SCOPE, kit number PTHS10F; cc) SHOULDER ARTHROSCOPY SAH, kit number SASA18D; dd) SHOULDER ARTHROSCOPY SAH, kit number SASA18F; ee) TOTAL ORTHO SAH, kit number SATO27F; ff) TOTAL ORTHO SAH, kit number SATO27G; gg) PODIATRY PACK, kit number SMPD35; hh) SHOULDER PACK, kit number SMSH12; ii) MAJOR SETUP PACK, kit number SMSU17A; jj) TOTAL HIP, kit number SMTH39; kk) TOTAL KNEE, kit number SMTK21; ll) Knee Arthroscopy, kit number SPKA57Q; mm) SHOULDER ARTHROSCOPY, kit number SPSA58P; nn) Total Hip pack W-O Stryker, kit number SPTH50AF; oo) Total Knee pack W-O Stryker, kit number SPTK51AF; pp) UPPER EXTREMITY, kit number SRUE05M; qq) Arthroscopy Pack, kit number THAR35B; rr) Extremity Pack, kit number THEX27B ss) Shoulder Pack, kit number THSH07F tt) Total Joint, kit number THTJ22G uu) TOTAL HIP PACK, kit number WHTH07D vv) TOTAL HIP PACK, kit number WHTH07E ww) TOTAL KNEE, kit number WHTK06C xx) TOTAL KNEE, kit number WHTK06D yy) CARPAL TUNNEL WEXFORD PACK, kit number WXCT12E

Why it was recalled

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

a) AHHF15C, UDI/DI 00191072137524, Lot numbers:  696221, exp. 9/7/2023; 741221, exp. 9/16/2023; 787221, exp. 8/1/2023; 873221, exp. 5/7/2023;  b) AHHF15D, UDI/DI 00191072183552, Lot numbers:  890231, exp. 4/21/2024; 959231, exp. 2/10/2024; 652221, exp. 9/5/2023;  c) BBHP10E, UDI/DI none, Lot numbers:  678221, exp. 11/18/2023; 748221, exp. 9/9/2023; 811221, exp. 7/8/2023; 867221, exp. 5/13/2023; 969231, exp. 1/31/2024;  d) BBLE40B, UDI/DI none, Lot numbers:  679221, exp. 11/17/2023; 743221, exp. 9/14/2023;  e) BOCP70J, UDI/DI none, Lot numbers:  705221, exp. 10/22/2023; 747221, exp. 9/10/2023; 839221, exp. 6/10/2023;  f) BPAR65A, UDI/DI 00191072187444, Lot numbers:  960231, exp. 2/9/2024;  g) EMHP84, UDI/DI 00191072094650, Lot numbers:  934231, exp. 9/30/2023; 983231, exp. 10/26/2023; 678221, exp. 9/30/2023; 769221, exp. 8/19/2023; 805221, exp. 7/14/2023; 856221, exp. 5/24/2023; 891221, exp. 4/19/2023;  h) FHHI17V, UDI/DI none, Lot numbers:  708221, exp. 10/19/2023; 651221, exp. 12/15/2023; 939231, exp. 3/2/2024; 885231, exp. 4/25/2024;  i) GNTH06L, UDI/DI 00191072157416, Lot numbers:  896221, exp. 4/14/2023; 778221, exp. 8/10/2023;  j) GNTK07L, UDI/DI none, Lot numbers:  715221, exp. 10/12/2023; 974231, exp. 1/26/2024;  k) GUEX48I, UDI/DI none, Lot numbers:  680221, exp. 11/16/2023; 639221, exp. 12/27/2023; 981231, exp. 1/19/2024; 927231, exp. 3/14/2024;  l) GUMO40J, UDI/DI none, Lot numbers:  715221, exp. 10/12/2023; 638221, exp. 12/28/2023; 975231, exp. 1/25/2024; 893231, exp. 4/17/2024;  m) HITK58D, UDI/DI none, Lot numbers:  773221, exp. 8/15/2023; 717221, exp. 10/10/2023; 991231, exp. 1/9/2024; 935231, exp. 3/6/2024;  n) HNSH17H, UDI/DI none, Lot numbers:  741221, exp. 9/16/2023; 989231, exp. 1/11/2024; 949231, exp. 2/20/2024;  o) HNTH76M, UDI/DI none, Lot numbers:  848221, exp. 6/1/2023; 702221, exp. 10/25/2023; 980231, exp. 1/20/2024;  p) HNTK81M, UDI/DI none, Lot numbers:  731221, exp. 9/26/2023; 689221, exp. 11/7/2023; 966231, exp. 2/3/2024;  q) HOHP28, UDI/DI 00191072171009, Lot numbers:  724221, exp. 10/3/2023; 687221, exp. 11/9/2023; 990231, exp. 1/10/2024; 942231, exp. 2/27/2024;  r) HSGK80S, UDI/DI none, Lot numbers: 689221, exp. 11/7/2023; 668221, exp. 11/28/2023; 969231, exp. 1/31/2024; 932231, exp. 9/3/2024; 871231, exp. 5/9/2024;   s) JSLE08E, UDI/DI 00191072135773, Lot numbers:  895221, exp. 4/15/2023;  t) LVHD29, UDI/DI 00191072062512, Lot numbers:  737221, exp. 9/20/2023; 716221, exp. 10/11/2023; 681221, exp. 11/15/2023; 650221, exp. 12/16/2023; 989231, exp. 1/11/2024; 942231, exp. 2/27/2024;  u) MMEX19E, UDI/DI none, Lot numbers:  966231, exp. 2/3/2024; 893231, exp. 4/17/2024;  v) MMHP45E, UDI/DI none, Lot numbers:  879231, exp. 5/1/2024;  w) MMSP21H, UDI/DI none, Lot numbers:  927231, exp. 3/14/2024;  x) MMTH15E, UDI/DI none, Lot numbers:  688221, exp. 11/8/2023; 654221, exp. 12/12/2023; 968231, exp. 2/1/2024;  y) MMTK66E, UDI/DI none, Lot numbers:  680221, exp. 11/16/2023; 991231, exp. 1/9/2024;  z) MMUE31E, UDI/DI none, Lot numbers:  919231, exp. 3/22/2024;  aa) PTHS10D, UDI/DI 00191072131362, Lot numbers:  646221, exp. 12/20/2023; 675221, exp. 9/5/2023; 720221, exp. 10/7/2023; 778221, exp. 8/10/2023;  bb) PTHS10F, UDI/DI 00191072131362, Lot numbers:  918231, exp. 9/5/2023; 984231, exp. 1/16/2024;  cc) SASA18D, UDI/DI none, Lot numbers:  885221, exp. 4/25/2023;  dd) SASA18F, UDI/DI none, Lot numbers:  663221, exp. 12/3/2023; 701221, exp. 10/26/2023; 726221, exp. 10/012023; 800221, exp. 7/19/2023; 981231, exp. 1/19/2024;  ee) SATO27F, UDI/DI none, Lot numbers:  833221, exp. 6/16/2023; 870221, exp. 5/10/2023;  ff) SATO27G, UDI/DI none, Lot numbers:  652221, exp. 12/14/2023; 695221, exp. 11/1/2023; 722221, exp. 10/5/2023; 756221, exp. 9/1/2023; 7912210, exp. 7/28/2023; 925231, exp. 3/16/2024; 954321, exp. 2/15/2024; 989231, exp. 1/11/2024;  gg) SMPD35, UDI/DI  00191072188496, Lot numbers:  961231, exp. 2/8/2024;  hh) SMSH12, UDI/DI  00191072188502, Lot numbers:  970231, exp. 1/30/2024; 899231, exp. 4/11/2024;  ii) SMSU17A, UDI/DI  00191072188519, Lot numbers:  938231, exp. 3/3/2024; 918231, exp. 3/23/2024; jj) SMTH39, UDI/DI  00191072188526, Lot numbers:  961231, exp. 2/8/2024; 928231, exp. 3/13/2024;  kk) SMTK21, UDI/DI  00191072188533, Lot numbers:  968231, exp. 2/1/2024; 928231, exp. 3/13/2024;  ll) SPKA57Q, UDI/DI  00191072163479, Lot numbers:  773221, exp. 8/15/2023; 707221, exp. 10/20/2023;  mm) SPSA58P, UDI/DI  00191072105264, Lot numbers:  775221, exp. 8/13/2023; 706221, exp. 10/21/2023;  nn) SPTH50AF, UDI/DI  00191072163448, Lot numbers:  833221, exp. 6/16/2023; 797221, exp. 7/22/2023;  oo) SPTK51AF, UDI/DI  00191072163486, Lot numbers:  709221, exp. 10/18/2023; 702221, exp. 10/25/2023;  pp) SRUE05M, UDI/DI  00191072185761, Lot numbers:  878231, exp. 5/2/2024;  qq) THAR35B, UDI/DI  00191072153340, Lot numbers:  708221, exp. 10/19/2023; 701221, exp. 10/26/2023;  rr) THEX27B, UDI/DI  00191072166074, Lot numbers:  778221, exp. 8/10/2023; 687221, exp. 11/9/2023;  ss) THSH07F, UDI/DI  00191072163493, Lot numbers:  791221, exp. 7/28/2023; 741221, exp. 9/16/2023;  tt) THTJ22G, UDI/DI  00191072189889, Lot numbers:  716221, exp. 10/11/2023; 708221, exp. 10/19/2023;  uu) WHTH07D, UDI/DI none, Lot numbers:  693221, exp. 11/3/2023; 730221, exp. 9/27/2023; 772221, exp. 8/16/2023; 804221, exp. 7/15/2023; 856221, exp. 5/24/2023;  vv) WHTH07E, UDI/DI none, Lot numbers:  646221, exp. 12/20/2023; 933231, exp. 3/18/2024; 969231, exp. 1/31/2024; 991231, exp. 1/9/2024;  ww) WHTK06C, UDI/DI none, Lot numbers:  709221, exp. 10/18/2023; 766221, exp. 8/22/2023; 806221, exp. 7/13/2023; 861221, exp. 5/19/2023;  xx) WHTK06D, UDI/DI none, Lot numbers:  654221, exp. 12/12/2023; 966231, exp. 2/3/2023;  yy) WXCT12E, UDI/DI  00191072053671, Lot numbers:  959231, exp. 2/10/2024; 696221, exp. 10/31/2023; 703221, exp. 10/24/2023; 731221, exp. 9/26/2023; 786221, exp. 8/2/2023; 862221, exp. 5/18/2023;

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

US Nationwide distribution.

Recall record

Recalling firm: American Contract Systems, Inc.
Product type: Devices
Recall number: Z-0833-2024
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: E-Mail
Origin: Temple Terrace, FL
Recall initiated: 2023-11-29

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-0833-2024 · Source: openFDA enforcement.