Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit ...
FDA Device Recall #Z-0833-2024 — Class II — November 29, 2023
Recall Summary
| Recall Number | Z-0833-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 29, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | American Contract Systems, Inc. |
| Location | Temple Terrace, FL |
| Product Type | Devices |
| Quantity | 5524 units |
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
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 Pattern
US Nationwide distribution.
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;
Other Recalls from American Contract Systems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1916-2025 | Class II | LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREM... | Apr 21, 2025 |
| Z-1426-2025 | Class II | Brand Name: Banner University Med Ctr. Produ... | Jan 31, 2025 |
| Z-1425-2025 | Class II | Brand Name: Banner Health Systems Product Name... | Jan 31, 2025 |
| Z-1424-2025 | Class II | Brand Name: Banner Health Systems Product Name... | Jan 31, 2025 |
| Z-3244-2024 | Class II | Pacemaker, COPM11B; Medical convenience kit | Aug 7, 2024 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.