Reported Feb 7, 2024 · Ongoing
Custom procedural convenience kits and trays, Othopedic use, labeled as
American Contract Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems, Inc. · 7802 E Telecom Pkwy · Temple Terrace, FL · 33637-0928
Is this the product you have?
Custom procedural convenience kits and trays, Othopedic use, labeled as
26 of 26 products
| # | Product as published |
|---|---|
| 1 | HIP FRACTURE, kit number AHHF15C |
| 2 | HIP FRACTURE, kit number AHHF15D |
| 3 | Hand Pack, kit number BBHP10E |
| 4 | Lower Extremity, kit number BBLE40B |
| 5 | Custom Podiatry, kit number BOCP70J |
| 6 | ROBOTIC PACK, kit number BPAR65A |
| 7 | HIP PINNING PACK, kit number EMHP84 |
| 8 | HIP PINNING PK, STRL F G, kit number FHHI17V |
| 9 | TOTAL HIP PACK, kit number GNTH06L |
| 10 | TOTAL KNEE PACK, kit number GNTK07L |
| 11 | EXTREMITY PACK, kit number GUEX48I |
| 12 | MAJOR ORTHO PACK, kit number GUMO40J |
| 13 | TOTAL KNEE ACCESS PACK, kit number HITK58D |
| 14 | SHOULDER ARTHROSCOPY, kit number HNSH17H |
| 15 | TOTAL HIP PACK, kit number HNTH76M |
| 16 | TOTAL KNEE PACK, kit number HNTK81M |
| 17 | ORIF HIP PACK, kit number HOHP28 |
| 18 | DR. GREENWALD TOTAL KNEE, kit number HSGK80S |
| 19 | Custom Lower Ext, kit number JSLE08E |
| 20 | HAND PACK, kit number LVHD29 |
- Lot codes and dates
26 of 26 products
Products covered by this recall # Barcodes Product as published 1 00191072137524AHHF15C, 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 2 00191072183552AHHF15D, UDI/DI 00191072183552, Lot numbers: 890231, exp. 4/21/2024; 959231, exp. 2/10/2024; 652221, exp. 9/5/2023 3 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 4 BBLE40B, UDI/DI none, Lot numbers: 679221, exp. 11/17/2023; 743221, exp. 9/14/2023 5 BOCP70J, UDI/DI none, Lot numbers: 705221, exp. 10/22/2023; 747221, exp. 9/10/2023; 839221, exp. 6/10/2023 6 00191072187444BPAR65A, UDI/DI 00191072187444, Lot numbers: 960231, exp. 2/9/2024 7 00191072094650EMHP84, 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 8 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 9 00191072157416GNTH06L, UDI/DI 00191072157416, Lot numbers: 896221, exp. 4/14/2023; 778221, exp. 8/10/2023 10 GNTK07L, UDI/DI none, Lot numbers: 715221, exp. 10/12/2023; 974231, exp. 1/26/2024 11 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 12 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 13 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 14 HNSH17H, UDI/DI none, Lot numbers: 741221, exp. 9/16/2023; 989231, exp. 1/11/2024; 949231, exp. 2/20/2024 15 HNTH76M, UDI/DI none, Lot numbers: 848221, exp. 6/1/2023; 702221, exp. 10/25/2023; 980231, exp. 1/20/2024 16 HNTK81M, UDI/DI none, Lot numbers: 731221, exp. 9/26/2023; 689221, exp. 11/7/2023; 966231, exp. 2/3/2024 17 00191072171009HOHP28, 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 18 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 19 00191072135773JSLE08E, UDI/DI 00191072135773, Lot numbers: 895221, exp. 4/15/2023 20 00191072062512LVHD29, 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 - Amount recalled
- 5524 units
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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