{ "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": "122360", "product_res_number": "Z-0391-2014", "event_date_initiated": "2013-06-22", "event_date_posted": "2013-11-26", "recall_status": "Terminated", "event_date_terminated": "2015-09-10", "res_event_number": "66416", "product_code": "HXP", "product_description": "Synthes Matrix 5.5.mm Left and Right Coronal Bender \n\nProduct Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine through screw and/or hook and rod fixation.", "code_info": "Parts 03.632.040 and 03.632.041 with various lot nos.  Item\tLot Number\tNumber \t 03.632.040\t T935338 03.632.040 T939100 03.632.040\t T945062 03.632.040\t T953982 03.632.040\t T956310 03.632.040\t T959990 03.632.040\t T959995 \t \t Item\tLot Number\tNumber \t 03.632.041\t T935343 03.632.041\t T939105 03.632.041\t T939755 03.632.041\t T945067 03.632.041\t T952750 03.632.041\t T956315 03.632.041\t T960000 03.632.041\t T960005", "firm_fei_number": "3005180112", "recalling_firm": "Synthes USA HQ, Inc.", "address_1": "1302 Wrights Ln E", "city": "West Chester", "state": "PA", "postal_code": "19380-3417", "additional_info_contact": "Customer Support\n610-719-5000", "reason_for_recall": "A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending a spinal rod component of the Matrix System.", "root_cause_description": "Component design/selection", "action": "Synthes sent an Urgent Notice: Medical Device Recall letter dated June 22, 2013 to users and sales reps. The letter identified the affected product, problem and actions to be taken. For questions call 610-719-5450.", "product_quantity": "209", "distribution_pattern": "Worldwide Distribution - USA (nationwide) including GA, FL, CA, UT, IA, AZ, OH and Internationally to Canada.", "openfda": { "k_number": [ "K800733", "K800732", "K872858", "K800730", "K800731" ], "registration_number": [ "3017435639", "3003120897", "3013055499", "3021010222", "1057946", "3018094310", "3030188041", "2031910", "8043971", "3031240334", "3007878094", "3009158523", "3004369035", "9614093", "3004944585", "9610612", "3016050940", "3002949614", "8043507", "1000517406", "3005528784", "2031009", "9613910", "9612074", "3010303097", "1833506", "8043862", "1526439", "2647346", "3012447612", "3016443334", "3006215390", "3011295718", "3009540749", "3022159082", "9680619", "3009887475", "3015399803", "3004983210", "2132732", "3033509898", "3011354099", "3017565094", "1828464", "3005641619", "1824199", "3006846753", "2029447", "3015877656", "3023852420", "3010235355", "8010665", "2249418", "3010049501", "9617297", "9611390", "3002976036", "2916714", "3015882686", "9680518", "1834331", "3009554293", "1649379", "3020584246", "3013156185", "3006639944", "3004187715", "3009882675", "3009417901", "3010009693", "3006524618", "8010944", "3005031160", "1043653", "9611813", "9610905", "3014967149", "3007887127", "1935627", "3010097171", "1056350", "1030489", "1057425", "1417592", "3006984710", "3004976965", "1836161", "3014314623", "3009998573", "3013011598", "3008583793", "1649390", "3006460162", "9611579", "3006946279", "3017521423", "9610809", "3004464325", "3009106092", "3013846070", "1219518", "3011513267", "9710629", "3038187464", "3005739886", "3036795921", "3010041511", "3009509485", "3004638532", "1822565", "3015876273", "3007143290", "1720747", "1421101", "3005061536", "9616250", "8043769", "3001239363", "1825034", "3038503932", "3005695838", "3010646402", "8030607", "2027467", "3011530718", "3010531060", "3012995405", "3015212339", "3005751028", "3010687973", "9613926", "9611112", "3011196443", "3000270450", "3038195984", "3005677016", "1020279", "3005067367", "3011137372", "3019878714", "3016032497", "3007366790", "3003696170", "3012120772", "9616944", "3033536312", "3011365613", "3008812560", "3003477135", "3009971621", "3009888740", "3025603301", "3036756245", "3007648354", "1828288", "2249529", "1424434", "3005827567", "1836357", "3006128100", "3034676720" ], "fei_number": [ "3017435639", "3003120897", "3010813691", "3002807373", "3000718490", "3013055499", "3021010222", "3018094310", "3030188041", "3007282753", "3031240334", "3005304066", "3007878094", "3009158523", "3004369035", "3004944585", "1000179044", "3016050940", "3002949614", "1000220733", "1000517406", "3005528784", "3002807464", "3002807072", "3002806685", "3010303097", "1526439", "2647346", "3012447612", "3005747797", "3016443334", "3006215390", "3011295718", "3009540749", "3022159082", "1832656", "3009887475", "3015399803", "3004983210", "3002806773", "3033509898", "3011354099", "3017565094", "1828464", "3005641619", "1824199", "3006846753", "3015877656", "3023852420", "3010235355", "3010049501", "3002976036", "2916714", "3003200961", "3015882686", "3009554293", "3002926812", "3020584246", "3013156185", "3004574120", "3006639944", "3004187715", "3001026312", "2183899", "3009417901", "3010009693", "3001406084", "3005031160", "1043653", "3003407235", "1000221916", "3014967149", "3007887127", "1000525271", "3010097171", "3000718467", "1935627", "3008782585", "3002795782", "1417592", "3006984710", "1000140363", "3004976965", "3014314623", "3002904345", "3009256700", "3002806545", "3002802903", "3009998573", "3013011598", "3002750084", "3008583793", "1000272060", "3006460162", "3006946279", "3003064967", "3017521423", "3004464325", "3009106092", "1000306340", "3001236812", "3013846070", "1219518", "3011513267", "3038187464", "3005739886", "3036795921", "3010041511", "3009509485", "3004638532", "3015876273", "3546", "3007143290", "1720747", "3002806315", "1421101", "3005061536", "3000041196", "3002786339", "3001239363", "1825034", "3038503932", "3005695838", "3010646402", "1000405819", "2027467", "3011530718", "3010531060", "3012995405", "3015212339", "3005751028", "3010687973", "3011196443", "3000270450", "3038195984", "3005677016", "1020279", "3019878714", "3016032497", "3003414678", "3003696170", "3012120772", "1000402972", "3003772581", "3033536312", "3011365613", "3008812560", "3003477135", "3009971621", "1000306694", "3009888740", "3025603301", "3036756245", "3007648354", "1000518793", "1828288", "1000477302", "3005827567", "3006509795", "3006128100", "3034676720" ], "device_name": "Instrument, Bending Or Contouring", "medical_specialty_description": "Orthopedic", "regulation_number": "888.4540", "device_class": "1" } } ] }