{ "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": "183681", "product_res_number": "Z-0081-2021", "event_date_initiated": "2020-09-04", "event_date_created": "2020-10-08", "recall_status": "Terminated", "event_date_terminated": "2021-08-31", "res_event_number": "86424", "product_code": "MBH", "k_numbers": [ "K080361" ], "product_description": "Biomet Regenerex Primary Taper Cap\nItem Number 141269", "code_info": "Lot Numbers: 015800 324440 685300 023900 324440R 696280 058930 389060 821980 200720 418430 890320 313260 646040 997610", "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\n574-371-3071", "reason_for_recall": "Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized", "root_cause_description": "Process change control", "action": "Zimmer Biomet notified on 9/2/20 Distributors with direct sales and/or fielded inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory, as well as hospitals that have consumed products in the past 12 months will be notified via FedEx. Surgeons that have consumed products with in the past 12 months notified via FedEx.\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. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form will be returned even if you do not have affected products at your facility.\n4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.\n5. If 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.\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.\n3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com.\n4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.\n5. If you ha", "product_quantity": "US: 62 units; OUS:\t176 units", "distribution_pattern": "Nationwide\nForeign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM", "openfda": { "k_number": [ "K141635", "K123459", "K080842", "K053340", "K143366", "K210308", "K242543", "K122745", "K202194", "K252777", "K031462", "K162256", "K032108", "K181794", "K172634", "K200782", "K233507", "K051380", "K153776", "K061223", "K212941", "K063731", "K140075", "K243768", "K060303", "K253189", "K253239", "K250980", "K153586", "K143393", "K253161", "K041872", "K170288", "K032905", "K223316", "K140883", "K141056", "K123486", "K120990", "K140881", "K150090", "K061521", "K242412", "K071107", "K243615", "K140735", "K033971", "K043083", "K253637", "K191084", "K051510", "K222566", "K063128", "K030612", "K140257", "K171365", "K211221", "K080361", "K122160", "K221705", "K043374", "K073325", "K102896", "K230295", "K110950", "K030623", "K072619", "K132624", "K243247", "K190991", "K210566", "K070214", "K240938", "K240678", "K122053", "K122218", "K070883", "K062654", "K141840", "K153657", "K150680", "K240299", "K071417", "K200113", "K152252", "K251840", "K033972", "K031061", "K050222", "K132873", "K201084", "K032418", "K220049", "K201364", "K253328", "K221850", "K093533", "K172524", "K240393", "K093405", "K182346", "K081479", "K173849", "K053505", "K072160", "K083782", "K091543", "K232426", "K243656", "K061433", "K203779", "K033489", "K041100", "K180317", "K103517", "K121771", "K140302", "K212746", "K241597", "K252044", "K071790", "K232303", "K072575", "K141407", "K173417", "K213781", "K032683", "K102927", "K100897", "K223548", "K210554", "K193312", "K121393", "K171991", "K152298", "K150832", "K040487", "K103598", "K211246", "K110533", "K032163", "K213817", "K243293" ], "device_name": "Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3565", "device_class": "2", 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