Class 2 Device Recall Custom procedural convenience kits and trays

• Date Initiated by Firm: November 29, 2023
• Date Posted: January 26, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0833-2024
• Recall Event ID: 93656
• Product Classification: Orthopedic tray - Product Code OJH
• Product: 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
• 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
• Recalling Firm/ Manufacturer: American Contract Systems, Inc.; 7802 E Telecom Pkwy; Temple Terrace FL 33637-0928
• For Additional Information Contact: Marlene Jones ; 470-280-4277
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: Owens & Minor issued an URGENT: MEDICAL DEVICE CORRECTION notice to it consignees on 11/29/2023 via email. Then notice explained the problem, risk to health, and requested the following actions be taken: If you received any of the batches/lots identified, please segregate and quarantine all affected product. Add warning labels to all kits/cases impacted: A labeling template is enclosed for printing warning labels which should be affixed to all affected product in inventory. This label should be affixed to each affected kit and case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. " Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. " Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified of this field correction and maintain records of effectiveness. Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com.
• Quantity in Commerce: 5524 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.