{ "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": "112648", "product_res_number": "Z-0386-2013", "event_date_initiated": "2012-08-27", "event_date_posted": "2012-11-20", "recall_status": "Terminated", "event_date_terminated": "2013-08-27", "res_event_number": "63126", "product_code": "KWZ", "k_numbers": [ "K071718" ], "product_description": "Trilogy II Constrained Liner\n\n The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.", "code_info": "Item 00-6334-062-36, Lot 62023769", "firm_fei_number": "1000220733", "recalling_firm": "Zimmer, Inc.", "address_1": "345 E Main St", "city": "Warsaw", "state": "IN", "postal_code": "46580-2746", "additional_info_contact": "Dona Reust\n574-372-4807", "reason_for_recall": "Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton.", "root_cause_description": "Labeling Change Control", "action": "Zimmer contacted their customer beginning the week of August 27, 2012, via telephone. Zimmer informed the customer the reason of the recall. \n\nThe customer was instructed to quarantine and return the device to Zimmer Product Service, 1777 W. Center St. Warsaw, IN 46580. The customer was asked to provide information if the product was further distributed. \n\nFor further questions please call 574-372-4316.", "product_quantity": "1", "distribution_pattern": "USA (nationwide) including the states of Ohio, Carolinas and New England.", "openfda": { "k_number": [ "K021728", "K043058", "K163497", "K030047", "K030923", "K122139", "K950202", "K071059", "K240639", "K063445", "K162641", "K071117", "K101730", "K890197", "K071676", "K083566", "K052079", "K870271", "K803192", "K111635", "K063552", "K161610", "K061654", "K072121", "K241461", "K033442", "K040601", "K021803", "K021661", "K071718", "K023794", "K063550", "K040225", "K021826" ], "pma_number": [ "P960047", "P960054" ], "registration_number": [ "1020279", "3002806535", "8010916", "3005551626", "3012392319", "2134285", "3006395932", "3010041693", "1000577893", "3002807315", "1531174", "1822565", "1828288", "3009973505", "3013055499", "1423662", "9613350", "3007120646", "1644408", "3010314800", "3015542154", 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