{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 9 } }, "results": [ { "cfres_id": "219540", "product_res_number": "Z-1985-2026", "event_date_initiated": "2026-04-03", "event_date_posted": "2026-04-29", "recall_status": "Open, Classified", "res_event_number": "98707", "product_code": "KRO", "k_numbers": [ "K242871" ], "product_description": "Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.", "code_info": "Part Number: 150450104. UDI-DI: 10603295533115. Lot Number: 1007844. Expiration Date: 11/30/2035", "firm_fei_number": "3002854251", "recalling_firm": "DEPUY (IRELAND)", "address_1": "Loughbeg, Ringaskiddy Loughbeg", "city": "Ringaskiddy Co. Cork", "country": "Ireland", "additional_info_contact": "Kimberly Long\n574-221-8156", "reason_for_recall": "The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.", "root_cause_description": "Under Investigation by firm", "action": "Depuy Ireland notified consignees on about 04/03/2026 via email. Consignees were instructed to examine inventory for affected units and immediately quarantine them, arrange for the return of all affected units, and complete and return the provided Business Response Form. Consignees were also instructed to forward the notification letter to anyone within each facility that needs to be informed, notify customers if affected units were further distributed and post a copy of the notification letter in a visible area for awareness.", "product_quantity": "3 units", "distribution_pattern": "US Nationwide distribution in the states of MN, NC, TX.", "openfda": { "k_number": [ "K230416", "K233980", "K003504", "K191779", "K101815", "K031804", "K013031", "K211677", "K121029", "K982160", "K130299", "K031480", "K021714", "K091453", "K821340", "K223528", "K252898", "K192798", "K223069", "K070978", "K823420", "K240043", "K083827", "K001548", "K051570", "K020381", "K140898", "K041352", "K092138", "K172347", "K781971", "K140509", "K110940", "K910596", "K151118", "K945028", "K811105", "K002552", "K060131", "K080330", "K083779", "K823115", "K211768", "K062301", "K210010", "K081111", "K072367", "K994207", "K163311", "K013340", "K242871", "K150028", "K910877", "K152431", 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