{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184784", "product_res_number": "Z-0629-2021", "event_date_initiated": "2020-11-25", "event_date_posted": "2020-12-17", "recall_status": "Terminated", "event_date_terminated": "2024-05-08", "res_event_number": "86896", "product_code": "JEY", "k_numbers": [ "K972322" ], "product_description": "Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone", "code_info": "Lot 078390", "firm_fei_number": "1825034", "recalling_firm": "Biomet, Inc.", "address_1": "56 E Bell Dr", "city": "Warsaw", "state": "IN", "postal_code": "46582-6989", "additional_info_contact": "411 Technical Services\n574-372-3071", "reason_for_recall": "Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.", "root_cause_description": "Process control", "action": "On November 25, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed of the potential loss of sterility in affected devices. \n\nCustomers were asked to do the following:\n\nRisk Manager Responsibilities:\n1. Review this notification and ensure that affected personnel are aware of the contents.\n2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.\n3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation.\n\nSurgeon Responsibilities:\n1. Review this notification for awareness of the contents.\n2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.\n\nAll customers should also complete the certificate of acknowledgement included with the letter and return to the firm.\n\nIf you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.", "product_quantity": "7428", "distribution_pattern": "Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, \nCANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN", "openfda": { "k_number": [ "K951687", "K943348", "K862482", "K130840", "K000560", "K854886", "K901095", "K111761", "K012413", "K924138", "K980927", "K020505", "K002083", "K061881", "K120951", "K010499", "K003660", "K193143", "K963740", "K121589", "K840955", "K950045", "K983360", "K061507", "K192747", "K000594", "K862505", "K862139", "K013055", "K172572", "K121235", "K021684", "K233874", "K983885", "K051236", "K950595", "K102641", "K103778", "K182759", "K221855", "K974555", "K193136", "K001238", "K230733", "K951690", "K052444", "K021382", "K022012", "K855030", "K180962", "K232350", "K021511", "K173039", "K003786", "K970841", "K963394", "K873926", "K143338", "K992158", "K022005", "K230398", "K083388", "K023486", "K992682", "K973484", "K983535", "K910038", "K172354", "K002879", "K050608", "K992905", "K884523", "K943345", 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