{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "205165", "product_res_number": "Z-0833-2024", "event_date_initiated": "2023-11-29", "event_date_posted": "2024-01-26", "recall_status": "Open, Classified", "res_event_number": "93656", "product_code": "OJH", "product_description": "Custom procedural convenience kits and trays, Othopedic use, labeled as: \na)\tHIP FRACTURE, kit number AHHF15C; \nb)\tHIP FRACTURE, kit number AHHF15D; \nc)\tHand Pack, kit number BBHP10E; \nd)\tLower Extremity, kit number BBLE40B; \ne)\tCustom Podiatry, kit number BOCP70J; \nf)\tROBOTIC PACK, kit number BPAR65A; \ng)\tHIP PINNING PACK, kit number EMHP84; \nh)\tHIP PINNING PK, STRL F G, kit number FHHI17V; \ni)\tTOTAL HIP PACK, kit number GNTH06L; \nj)\tTOTAL KNEE PACK, kit number GNTK07L; \nk)\tEXTREMITY PACK, kit number GUEX48I; \nl)\tMAJOR ORTHO PACK, kit number GUMO40J; \nm)\tTOTAL KNEE ACCESS PACK, kit number HITK58D; \nn)\tSHOULDER ARTHROSCOPY, kit number HNSH17H; \no)\tTOTAL HIP PACK, kit number HNTH76M; \np)\tTOTAL KNEE PACK, kit number HNTK81M; \nq)\tORIF HIP PACK, kit number HOHP28; \nr)\tDR. GREENWALD TOTAL KNEE, kit number HSGK80S; \ns)\tCustom Lower Ext, kit number JSLE08E; \nt)\tHAND PACK, kit number LVHD29; \nu)\tKIT, LOWER EXTREMITY, kit number MMEX19E; \nv)\tKIT, HIP PINNING, kit number MMHP45E; \nw)\tKIT, ORTHO SPINE, kit number MMSP21H; \nx)\tKIT, TOTAL HIP, kit number MMTH15E; \ny)\tKIT, TOTAL KNEE, kit number MMTK66E; \nz)\tKIT, UPPER EXTREMITY OPEN SHOULDER, kit number MMUE31E; \naa)\tHIP SCOPE, kit number PTHS10D; \nbb)\tHIP SCOPE, kit number PTHS10F; \ncc)\tSHOULDER ARTHROSCOPY SAH, kit number SASA18D; \ndd)\tSHOULDER ARTHROSCOPY SAH, kit number SASA18F; \nee)\tTOTAL ORTHO SAH, kit number SATO27F; \nff)\tTOTAL ORTHO SAH, kit number SATO27G; \ngg)\tPODIATRY PACK, kit number SMPD35; \nhh)\tSHOULDER PACK, kit number SMSH12; \nii)\tMAJOR SETUP PACK, kit number SMSU17A; \njj)\tTOTAL HIP, kit number SMTH39; \nkk)\tTOTAL KNEE, kit number SMTK21; \nll)\tKnee Arthroscopy, kit number SPKA57Q; \nmm)\tSHOULDER ARTHROSCOPY, kit number SPSA58P; \nnn)\tTotal Hip pack W-O Stryker, kit number SPTH50AF; \noo)\tTotal Knee pack W-O Stryker, kit number SPTK51AF; \npp)\tUPPER EXTREMITY, kit number SRUE05M; \nqq)\tArthroscopy Pack, kit number THAR35B; \nrr)\tExtremity Pack, kit number THEX27B\nss)\tShoulder Pack, kit number THSH07F\ntt)\tTotal Joint, kit number THTJ22G\nuu)\tTOTAL HIP PACK, kit number WHTH07D\nvv)\tTOTAL HIP PACK, kit number WHTH07E\nww)\tTOTAL KNEE, kit number WHTK06C\nxx)\tTOTAL KNEE, kit number WHTK06D\nyy)\tCARPAL TUNNEL WEXFORD PACK, kit number WXCT12E", "code_info": "a)\tAHHF15C, 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; \nb)\tAHHF15D, UDI/DI 00191072183552, Lot numbers: 890231, exp. 4/21/2024; 959231, exp. 2/10/2024; 652221, exp. 9/5/2023; \nc)\tBBHP10E, 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; \nd)\tBBLE40B, UDI/DI none, Lot numbers: 679221, exp. 11/17/2023; 743221, exp. 9/14/2023; \ne)\tBOCP70J, UDI/DI none, Lot numbers: 705221, exp. 10/22/2023; 747221, exp. 9/10/2023; 839221, exp. 6/10/2023; \nf)\tBPAR65A, UDI/DI 00191072187444, Lot numbers: 960231, exp. 2/9/2024; \ng)\tEMHP84, 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; \nh)\tFHHI17V, 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; \ni)\tGNTH06L, UDI/DI 00191072157416, Lot numbers: 896221, exp. 4/14/2023; 778221, exp. 8/10/2023; \nj)\tGNTK07L, UDI/DI none, Lot numbers: 715221, exp. 10/12/2023; 974231, exp. 1/26/2024; \nk)\tGUEX48I, 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; \nl)\tGUMO40J, 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; \nm)\tHITK58D, 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; \nn)\tHNSH17H, UDI/DI none, Lot numbers: 741221, exp. 9/16/2023; 989231, exp. 1/11/2024; 949231, exp. 2/20/2024; \no)\tHNTH76M, UDI/DI none, Lot numbers: 848221, exp. 6/1/2023; 702221, exp. 10/25/2023; 980231, exp. 1/20/2024; \np)\tHNTK81M, UDI/DI none, Lot numbers: 731221, exp. 9/26/2023; 689221, exp. 11/7/2023; 966231, exp. 2/3/2024; \nq)\tHOHP28, 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; \nr)\tHSGK80S, 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; \ns)\tJSLE08E, UDI/DI 00191072135773, Lot numbers: 895221, exp. 4/15/2023; \nt)\tLVHD29, 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; \nu)\tMMEX19E, UDI/DI none, Lot numbers: 966231, exp. 2/3/2024; 893231, exp. 4/17/2024; \nv)\tMMHP45E, UDI/DI none, Lot numbers: 879231, exp. 5/1/2024; \nw)\tMMSP21H, UDI/DI none, Lot numbers: 927231, exp. 3/14/2024; \nx)\tMMTH15E, UDI/DI none, Lot numbers: 688221, exp. 11/8/2023; 654221, exp. 12/12/2023; 968231, exp. 2/1/2024; \ny)\tMMTK66E, UDI/DI none, Lot numbers: 680221, exp. 11/16/2023; 991231, exp. 1/9/2024; \nz)\tMMUE31E, UDI/DI none, Lot numbers: 919231, exp. 3/22/2024; \naa)\tPTHS10D, 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; \nbb)\tPTHS10F, UDI/DI 00191072131362, Lot numbers: 918231, exp. 9/5/2023; 984231, exp. 1/16/2024; \ncc)\tSASA18D, UDI/DI none, Lot numbers: 885221, exp. 4/25/2023; \ndd)\tSASA18F, 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; \nee)\tSATO27F, UDI/DI none, Lot numbers: 833221, exp. 6/16/2023; 870221, exp. 5/10/2023; \nff)\tSATO27G, 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; \ngg)\tSMPD35, UDI/DI 00191072188496, Lot numbers: 961231, exp. 2/8/2024; \nhh)\tSMSH12, UDI/DI 00191072188502, Lot numbers: 970231, exp. 1/30/2024; 899231, exp. 4/11/2024; \nii)\tSMSU17A, UDI/DI 00191072188519, Lot numbers: 938231, exp. 3/3/2024; 918231, exp. 3/23/2024;\njj)\tSMTH39, UDI/DI 00191072188526, Lot numbers: 961231, exp. 2/8/2024; 928231, exp. 3/13/2024; \nkk)\tSMTK21, UDI/DI 00191072188533, Lot numbers: 968231, exp. 2/1/2024; 928231, exp. 3/13/2024; \nll)\tSPKA57Q, UDI/DI 00191072163479, Lot numbers: 773221, exp. 8/15/2023; 707221, exp. 10/20/2023; \nmm)\tSPSA58P, UDI/DI 00191072105264, Lot numbers: 775221, exp. 8/13/2023; 706221, exp. 10/21/2023; \nnn)\tSPTH50AF, UDI/DI 00191072163448, Lot numbers: 833221, exp. 6/16/2023; 797221, exp. 7/22/2023; \noo)\tSPTK51AF, UDI/DI 00191072163486, Lot numbers: 709221, exp. 10/18/2023; 702221, exp. 10/25/2023; \npp)\tSRUE05M, UDI/DI 00191072185761, Lot numbers: 878231, exp. 5/2/2024; \nqq)\tTHAR35B, UDI/DI 00191072153340, Lot numbers: 708221, exp. 10/19/2023; 701221, exp. 10/26/2023; \nrr)\tTHEX27B, UDI/DI 00191072166074, Lot numbers: 778221, exp. 8/10/2023; 687221, exp. 11/9/2023; \nss)\tTHSH07F, UDI/DI 00191072163493, Lot numbers: 791221, exp. 7/28/2023; 741221, exp. 9/16/2023; \ntt)\tTHTJ22G, UDI/DI 00191072189889, Lot numbers: 716221, exp. 10/11/2023; 708221, exp. 10/19/2023; \nuu)\tWHTH07D, 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; \nvv)\tWHTH07E, 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; \nww)\tWHTK06C, 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; \nxx)\tWHTK06D, UDI/DI none, Lot numbers: 654221, exp. 12/12/2023; 966231, exp. 2/3/2023; \nyy)\tWXCT12E, 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;", "firm_fei_number": "3003309947", "recalling_firm": "American Contract Systems, Inc.", "address_1": "7802 E Telecom Pkwy", "city": "Temple Terrace", "state": "FL", "postal_code": "33637-0928", "additional_info_contact": "Marlene Jones \n470-280-4277", "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.", "root_cause_description": "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:\nIf you received any of the batches/lots identified, please segregate and quarantine all affected product.\nAdd 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.\n\" Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have.\n\" 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. \nReport any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com.", "product_quantity": "5524 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "registration_number": [ "3015543569", "1450662", "9710629", "3045816907", "3004111573", "1417592", "3010667733", "3008864603", "1923569", "1043534", "3013552417", "3002807315", "3015173212", "3011430871", "3010052483", "1423395", "3017823294", "3035642068", "8031020", "1047429", "3018077422", "1928237", "3014170143", "3004122598", "1643817", "9616088", "3003477135", "3045816902", "2029015", "8044102", "3014554088", "3011187779", "3004911384", "3008534770", "3007329020", "1835444", "3017307654", "3009203853", "3007663067", "3007289408", "3005012805", "3009888344", "3008111820", "1423537", "1825034", "3012120772", "3005595283", "3008544874", "1123137", "3014680744", "1424263", "1061124", "1030451", "1221053", "3008395366", "1020279", "3015131017", "3006981798" ], "fei_number": [ "3015543569", "1450662", "3045816907", "3004111573", "1417592", "1000160458", "3000717925", "3000717687", "3003407235", "3008864603", "3010667733", "1923569", "1043534", "3013552417", "3002902735", "3002807315", "3015173212", "3011430871", "3010052483", "3035642068", "3017823294", "3013299874", "1047429", "3018077422", "1928237", "3014170143", "3004122598", "1000123180", "1643817", "3003477135", "3045816902", "1000512168", "3014554088", "3011187779", "3004911384", "3008534770", "3007329020", "3001236905", "3017307654", "3009203853", "3007663067", "3007289408", "3003015552", "3005012805", "3009888344", "3008111820", "3002807830", "1825034", "3006981798", "3012120772", "3005595283", "3008544874", "3014680744", "1221053", "1030451", "3008395366", "1020279", "3015131017" ], "device_name": "Orthopedic Tray", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4800", "device_class": "1" } } ] }