Class II Recall

Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HI

Summary

The FDA issued a Class II for Custom procedural convenience kits and trays, Othopedic use, labeled as: a) H by American Contract Systems, Inc.. Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization proces.

Details

Source

Device Recall

External ID

Z-0833-2024

Action Date

2024-02-07

Status

Ongoing

Product Description

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

Lot/Code Info: 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;

Quantity Affected: 5524 units

Reason for Recall

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.

Distribution

US Nationwide distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-11-29

Company

American Contract Systems, Inc.

Temple Terrace, FL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 221 device recalls issued in the same week, part of 403 device-related FDA actions this month.

American Contract Systems, Inc. has 188 FDA actions in our database, including 188 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (American Contract Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does American Contract Systems, Inc. have FDA actions?

American Contract Systems, Inc. has 188 FDA actions in our database, including 188 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0833-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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