{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "74060", "product_res_number": "Z-0288-2009", "event_date_initiated": "2008-09-24", "event_date_posted": "2008-11-09", "recall_status": "Terminated", "event_date_terminated": "2009-06-29", "res_event_number": "49709", "product_code": "JDQ", "k_numbers": [ "K982545" ], "product_description": "Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve, sterile, use w/2.0 MM S.S. cable # 350800, Biomet Orthopedics, Inc., Warsaw, IN; REF. 350805.\n\nIntended for general orthopedic repairs including long bone fractures, bone grafting, reinforcement of bone and reattachment of the greater trochanter.", "code_info": "Lot 568400.", "firm_fei_number": "1825034", "recalling_firm": "Biomet, Inc.", "address_1": "56 E Bell Dr", "city": "Warsaw", "state": "IN", "postal_code": "46582", "additional_info_contact": "800-348-9500", "reason_for_recall": "The outer package is properly labeled, but the inner package may be labeled as a femoral component.", "root_cause_description": "Labeling mix-ups", "action": "The firm's sales force was notified of the problem via an Urgent Medical Device Removal Notice letter dated 9/24/08, and provided instructions to retrieve the product from customer accounts and to provide them with a copy of the removal letter. Distributors were to immediately locate and remove the identified implants from circulation, carefully follow the instructions, and fax a copy of the Response Form prior to the return of the product. If the product was further distributed, hospital personnel MUST be notified via the enclosed \"Dear Biomet Customer\" notice. The letter MUST be given to hospital personnel responsible for receiving recall notices but distributors are charged with the location and return of those products.", "product_quantity": "48", "distribution_pattern": "Worldwide Distribution --- USA including states of Arkansas, Florida, Kansas, New Jersey, and Ohio, and countries of Argentina, Canada, Chile Italy, Mexico and United Kingdom.", "openfda": { "k_number": [ "K003951", "K953777", "K232986", "K875156", "K935481", "K010943", "K935646", "K973098", "K261271", "K102834", "K151848", "K081622", "K934557", "K110541", "K001254", "K984432", "K922142", "K120177", "K180582", "K932687", "K961569", "K232733", "K913735", "K934059", "K915581", "K961267", "K931246", "K103797", "K110039", "K151346", "K882890", "K161876", "K953818", "K151983", "K962162", "K151888", "K221795", "K971741", "K031508", "K121541", "K993286", "K920201", "K071271", "K091190", "K033816", "K982545", "K922952", "K143716", "K043252", "K230976", "K150889", "K220765", 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"3004893332" ], "device_name": "Cerclage, Fixation", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3010", "device_class": "2" } } ] }