{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184727", "product_res_number": "Z-0696-2021", "event_date_initiated": "2020-11-20", "event_date_created": "2020-12-22", "recall_status": "Terminated", "event_date_terminated": "2022-05-26", "res_event_number": "86869", "product_code": "HXZ", "product_description": "Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries.", "code_info": "All lots", "firm_fei_number": "1000220733", "recalling_firm": "Zimmer Biomet, Inc.", "address_1": "1800 W Center St", "city": "Warsaw", "state": "IN", "postal_code": "46580-2304", "additional_info_contact": "411 Technical Services\n574-371-3071", "reason_for_recall": "Device has the potential for fracture during use.", "root_cause_description": "Under Investigation by firm", "action": "The firm distributed Urgent Medical Device Recall and Notice of Discontinuation letters to affected customers on November 20, 2020. Customers were informed of the product's potential for fracture during use. Customers were asked to locate and quarantine affected product and to return all affected product to the firm.\n\nThe firm is discontinuing this product; it will not longer be available. \n\nIf you have questions regarding this recall, please contact the firm's 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": "4713", "distribution_pattern": "Domestic distribution nationwide. Foreign distribution to Australia, China, Hong Kong, India, Japan, Korea, New Zealand, Taiwan, Singapore, Thailand, Canada, Netherlands, Argentina, Brazil, Mexico, Venezuela, Panama, and Chile.", "openfda": { "registration_number": [ "3012103978", "3014334038", "3008583793", "3015895045", "3036795921", "3005695838", "3035708926", "8010379", "9611281", "3026311512", "3042248499", "9611458", "9613083", "3007507973", "3004464325", "3004049923", "3004215117", "1421879", "9613926", "3010509633", "3007125392", "3010097171", "3004992978", "3008812251", "3014938863", "3022748632", "9611827", "1825034", "3005273623", "3001084743", "1219518", "3007366790", "2249529", "3003882387", "9616250", "2027754", "8010099", "3002834291", "3014257776", "3014683120", "3003418325", "3009790163", "3010699884", "8010372", "3015515018", "1833053", "3006846753", "3005528784", "3006444232", "1835998", "3003526896", "3010235355", "2531195", "3007441485", "3009340886", "9610809", "3019455", "3005061536", "3004774118", "3033536312", "2087382", "9611503", "3006891796", "1421101", "8040278", "9611367", "3005225959", "3013031133", "1055890", "3027556548", "2085947", "3003431869", "3011371465", "9610612", "8043496", "8043622", "3010303097", "9616246", "2248030", "9614062", "3008808049", "8010168", "9680260", "1032347", "1219655", "9680411", "3008455034", "3007284437", "8010250", "3008770252", "5906", "1056350", "1057946", "3005677016", "9681622", "3003969055", "3031564283", "9611813", "3014201171", "2080222", "3005641619", "1061124", "3004371426", "3003244954", "9611610", "3005083075", "3008837339", "3031261833", "3004549189", "3005751028", "3004784004", "8010235", "3038503932", "1313525", "3008338766", "2936485", "3034676720", "9611390", "3029082594", "3006742481", "9681540", "3004111573", "9680515", "3010065126", "3035678069", "8010733", "3007648354", "3017521423", "3009417901", "3042285592", "3010646402", "9613079", "9710524", "3005067367", "3008534770", "8010665", "3005973280", "3012120772", "3018094310", "3006554912", "3006059835", "1424478", "3015876273", "3013846070", "3010829427", "3005621335", "3010041511", "9611274", "3005440795", "3006460162", "3007137643", "3005897698", "2031009", "3012501675", "2431166", "9680619", "3010687973", "3013946322", "3003120897", "3016443334", "3011137372", "3012447612", "9610905", "9612074", "3000327445", "1822565", "3038195984", "2132732", "3003322138", "1020279", "1833824", "2916714", "3010455030", "3034688516", "3004571672", "1824199", "1923569", "2529846", "9611283", "3004608878", "1417592", "8010839", "3006272282", "3006513362", "9613910", "3009468807", "3042172872", "3007751820", "3005809810", "3025380425", "8040884", "2434839", "3003644849", "9611062", "3022862651", "3005813597", "9680718", "9616088", "3012995405", "3032747418", "3012267976", "1030489", "8010528", "3016965929", "1423537", "3002675176", "1932180", "1836161", "3009513193", "8010159", "9611112", "8040233", "3004001706", "1646747", "8010769", "1526439", "8010732", "9680002", "8043971", "3002862271", "3003694247", "8030607", "2126670", "3016894896", "9612278", "9680518", "1720747", "3021666757", "3008812560", "3014615697", "9616671", "2031917", "3004504812", "3013540005", "1226544", "3004892425", "1828464", "2084346", "1422507", "8010257", "9680059", "3004530184", "3016050940", "3013011598", "3031240334", "1818910", "3009703496", "3000219976", "3015487912" ], "fei_number": [ "3012103978", "3014334038", "3008583793", "3015895045", "3036795921", "3005695838", "2523865", "3035708926", "3002807421", "3026311512", "3042248499", "1000208866", "1000306694", "3002807464", "3004464325", "3004049923", "3004215117", "3000183921", "7282", "3010509633", "3007125392", "3007282753", "3010097171", "3004992978", "3022748632", "3014938863", "1825034", "3005273623", "3001084743", "1000477302", "1219518", "3005969827", "3003772581", "3003882387", "2027754", "3002834291", "3014257776", "3000280067", "3014683120", "3010699884", "3003418325", "3009790163", "3015515018", "1833053", "1000119305", "3006846753", "3005528784", "3006444232", "3003526896", "3002750084", "3010235355", "1000115331", "5870", "3007441485", "3009340886", "3019455", "3005061536", "3033536312", "3006891796", "1421101", "3005225959", "1000140363", "3013031133", "3027556548", "3003431869", "3011371465", "3010303097", "3007290840", "3003944071", "3002902165", "3002806685", "3008808049", "3002808335", "3002809532", "1032347", "1219655", "3002786339", "3008455034", "3002808360", "3007284437", "3003052153", "3008770252", "5906", "3007803626", "3004051158", "3005677016", "3546", "3003969055", "3002808293", "3002807169", "3031564283", "2080222", "3014201171", "3005641619", "1000136191", "3003244954", "3003128516", "3002315844", "3001417518", "3005083075", "3008837339", "3031261833", "3005751028", "3004784004", "1000390051", "3004545991", "3038503932", "3008338766", "2936485", "3034676720", "3374", "3029082594", "3006742481", "3004574120", "3004111573", "3010065126", "1000518604", "3035678069", "1000124817", "3003499455", "3007648354", "3017521423", "3009417901", "3042285592", "3003386935", "3010646402", "1000272060", "3008782585", "1000525271", "3008534770", "3005973280", "3012120772", "3018094310", "3006554912", "3002807988", "3002807214", "3006059835", "1000115048", "4498", "3015876273", "3013846070", "3010829427", "3002807072", "3010041511", "3005621335", "3005440795", "3006460162", "3007137643", "3005897698", "3008599177", "3010034765", "3002808043", "3012501675", "3003914946", "3010687973", "3013946322", "3003120897", "3016443334", "3000327445", "3012447612", "3002854251", "3038195984", "3003322138", "1020279", "2916714", "3010455030", "3001236905", "3034688516", "3004571672", "1000453845", "3001236812", "1000160162", "3000207350", "1824199", "1923569", "1000402972", "3002806816", "3004608878", "1417592", "1000111204", "3006272282", "3006513362", "3009468807", "3042172872", "3007751820", "3000204191", "3025380425", "2434839", "3002807373", "3005809810", "3003644849", "3022862651", "1000512168", "3005813597", "3008237824", "3004369356", "3012995405", "3032747418", "6507", "3012267976", "1000199976", "3016965929", "3002675176", "3006509795", "3009513193", "3004001706", "3002806315", "3001026312", "1526439", "1000405819", "3002807395", "3002808003", "1000508235", "3002929183", "3000321209", "3002862271", "3003694247", "2126670", "3016894896", "1720747", "3021666757", "3008812560", "3014615697", "3002806862", "3002902735", "3004504812", "3005747797", "3013540005", "3002807264", "3005304066", "1000220733", "3003697160", "3004892425", "1828464", "1000159990", "3002806773", "3008205331", "3004530184", "3004216008", "1317628", "3016050940", "3002807183", "3013011598", "3031240334", "1818910", "3009703496", "3002807682", "3000219976", "3015487912" ], "device_name": "Cutter, Wire", "medical_specialty_description": "Orthopedic", "regulation_number": "888.4540", "device_class": "1", "k_number": [ "K873715" ] } } ] }