{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "199205", "product_res_number": "Z-1385-2023", "event_date_initiated": "2023-03-10", "event_date_posted": "2023-04-12", "recall_status": "Open, Classified", "res_event_number": "91913", "product_code": "HSX", "k_numbers": [ "K082172", "K090763" ], "product_description": "stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure", "code_info": "GTIN 00848486003746, Lot Number 26270421", "firm_fei_number": "3003070421", "recalling_firm": "Howmedica Osteonics Corp.", "address_1": "325 Corporate Dr", "city": "Mahwah", "state": "NJ", "postal_code": "07430-2006", "additional_info_contact": "Karina Strakhova Masullo\n201-831-5000", "reason_for_recall": "Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking", "root_cause_description": "Process change control", "action": "Stryker issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 03/10/2023 by letter. The notice explained the issue and the hazard and requested the following actions be taken: \n1.\tPlease inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware.\n2.\tImmediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility.\n3.\tQuarantine and discontinue use of the affected products in Table 1. \n4.\tComplete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to strykerortho5321@sedgwick.com/ fax (888) 266-7910. \n5.\tPlease contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions.\n6.\tPlease return ALL affected product to: Stryker Orthopaedics/PFA Product Return. \n\nStryker issued an URGENT MEDICAL DEVICE RECALL UPDATE notice to its consignees on 04/12/2023. The letter contained the same information, but added a section titled Recommendations for patients already treated with an affected device, and advised patients treated with an affected product should continue to be followed per the normal protocol established by his or her surgeon(s).", "product_quantity": "52 units", "distribution_pattern": "U.S., Netherlands, Japan, China, India, Korea, and Australia.", "openfda": { "k_number": [ "K910807", "K212870", "K232114", "K954186", "K120262", "K242711", "K853268", "K873970", "K011954", "K050373", "K915240", "K191150", "K803235", "K191211", "K162084", "K061011", "K992287", "K132640", "K173970", "K914439", "K203697", "K122529", "K203341", "K952068", "K200433", "K170344", "K063782", "K161741", "K191996", "K033769", "K200151", "K072586", "K212307", "K800640", "K844706", "K043570", "K063432", "K861715", "K921232", "K896648", "K161592", "K931214", "K090024", "K113038", "K945613", "K211471", "K926231", "K160738", "K161060", "K211895", "K181302", 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Femorotibial, Non-Constrained, Cemented, Metal/Polymer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3520", "device_class": "2" } } ] }