{ "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": "158816", "product_res_number": "Z-0298-2018", "event_date_initiated": "2017-06-05", "event_date_created": "2017-12-29", "recall_status": "Terminated", "event_date_terminated": "2018-03-06", "res_event_number": "78167", "product_code": "KWT", "k_numbers": [ "K023063" ], "product_description": "COMP 12MM HUM FRAC STEM MACRO, model # 11-113562", "code_info": "Lot Number: 529890", "firm_fei_number": "1825034", "recalling_firm": "Zimmer Biomet, Inc.", "address_1": "56 E Bell Dr", "city": "Warsaw", "state": "IN", "postal_code": "46582-6989", "reason_for_recall": "Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.", "root_cause_description": "Labeling False and Misleading", "action": "On June 5, 2017, Zimmer Biomet distributed Urgent Medical Device Recall notices to their customers via email and Fed Ex courier service. ***Risk Managers are advised to: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative to quarantine all affected product. 3. Work with your Zimmer Biomet sales representative in removing the affected product from your facility. 4. Confirm that the patient labels in your records are correct. 5. Complete the Certificate of Acknowledgement and return a digital copy to corporatequality.postmarket@zimmerbiomet.com and retain a copy of the Acknowledgement Form with your recall records in the event of a compliance audit of your facilities documentation. ****Distributors, Sales Reps & Distributor Operation Managers are advised to: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form and return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet.\na. Request a Recall Return Authorization Number via SMS or via email to rgarequest@zimmerbiomet.com (domestic) or via email to zimmerbiometintlirarequests@zimmerbiomet.com (international).\nb. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com.\nc. Include a hardcopy of Attachment 1 with your shipment for immediate processing. d. Mark the outside of the returns box(es) clearly with RECALL.\nCustomers with further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5", "distribution_pattern": "Nationwide in US; Internationally Argentina, Netherlands & Canada", "openfda": { "k_number": [ "K022079", "K802124", "K231657", "K991603", "K984541", "K182500", "K043505", "K223631", "K961571", "K110706", "K110791", "K050761", "K250713", "K103404", "K140071", "K991585", "K181287", "K940537", "K002998", "K982981", "K905786", "K191811", "K121543", "K895802", "K970567", "K010869", "K931114", "K162903", "K152825", "K042321", "K873621", "K111746", "K161476", "K831234", "K914695", "K922865", "K041549", "K914000", "K191698", "K873104", "K150730", "K101263", "K790987", "K915596", "K241817", "K222482", "K873620", "K100858", "K962238", "K962315", "K143659", "K022377", "K251686", "K960424", "K962244", "K872454", "K173812", "K032507", "K190595", "K833409", "K123814", "K071147", "K925613", 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