{ "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": "130294", "product_res_number": "Z-0057-2015", "event_date_initiated": "2014-09-26", "event_date_posted": "2014-10-09", "recall_status": "Terminated", "event_date_terminated": "2015-07-14", "res_event_number": "69360", "product_code": "HWQ", "product_description": "Green Mamba Suture Passer.\n\nThe Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.", "code_info": "Catalog Number: 110010850 Lot Number: 231120, 253210", "firm_fei_number": "1825034", "recalling_firm": "Biomet, Inc.", "address_1": "56 E Bell Dr", "city": "Warsaw", "state": "IN", "postal_code": "46581", "additional_info_contact": "Audrey Daenzer\n574-372-1570", "reason_for_recall": "An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.", "root_cause_description": "Nonconforming Material/Component", "action": "On 9/26/2014, \"URGENT MEDICAL DEVICE RECALL NOTICE\" notifications were sent via courier to the affected distributors with instructions for returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, contact information, and instructions for responding to the formal recall notification.", "product_quantity": "12 units", "distribution_pattern": "Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.", "openfda": { "k_number": [ "K811679", "K841623", "K970360", "K843592", "K885311", "K841622", "K920621", "K791960", "K923381" ], "registration_number": [ "3010331645", "3012358417", "1220477", "1421879", "2031917", "3011061237", "3014302784", "3012130008", "8043971", "1222928", "3010047454", "8044098", "3002808227", "9610612", "3002579136", "3000931034", "9611278", "3002807315", "3012448339", "3005528784", "2031009", "9613910", "3011302692", "2936485", "3010303097", "9615004", "3010635845", "3003694247", "3008110533", "3011295718", "3010060157", "3009540749", "3002907620", "3004983210", "3006513362", "3006846753", "8040278", "2032098", "2950160", "1221051", "1054811", "3008792120", "3015974593", "8010372", "3010536692", "2011171", "3034532468", "3021477808", "2916714", "1835998", "3008837339", "3009255580", "3020584246", "3042255021", "3008747271", "3010659131", "3006524618", "3007738736", "2183456", "3014023545", "1056350", "1417592", "1064017", "1836161", "3003418325", "3005809810", "3013756169", "3020704423", "3004608878", "1649390", "3006460162", "1526534", "3012267976", "8010177", "1833824", "3013497507", "3010273872", "3005180920", "3013846070", "1219518", "3031564283", "3010287687", "1220246", "3010041511", "3012102437", "3007507973", "3003139373", "3014334038", "8044102", "1822565", "3005575604", "1421101", "1017294", "1219602", "3007319107", "3007663067", "3003604053", "3045853999", "1825034", "3004215117", "3038503932", "3030535035", "3010667733", "8030607", "8010099", "3032391", "9613926", "9611112", "3026133770", "1020279", "3005067367", "3011137372", "1226230", "3007366790", "3009513193", "1061927", "3033536312", "3008812560", "2953359", "3009971621", "8031020", "3006981798", "1319639", "3008770252", "2249529", "1643264", "1043534", "1824313", "3043620689", "2183449", "3019269298" ], "fei_number": [ "3010331645", "3012358417", "3010813691", "1220477", "3011061237", "3014302784", "3012130008", "3010047454", "3007282753", "3002808227", "3002579136", "3000931034", "3002807315", "1000220733", "3012448339", "3001130644", "3005528784", "3007290840", "3011302692", "2936485", "3002821504", "3010303097", "3010635845", "3005747797", "3003694247", "3004028763", "3008110533", "3011295718", "3010060157", "3009540749", "3002907620", "3004983210", "3006513362", "3006846753", "5870", "1221051", "3008792120", "3015974593", "1000138054", "3010536692", "2011171", "3034532468", "3021477808", "2916714", "3008837339", "3000190635", "3002836339", "3009255580", "3020584246", "1000518604", "3004574120", "3042255021", "3008747271", "3010659131", "3000203000", "3007738736", "2183456", "3014023545", "3000718467", "3008782585", "3002929183", "1417592", "1000140363", "3003418325", "3005809810", "3013756169", "3020704423", "3004608878", "3002750084", "1000272060", "3006460162", "1526534", "3002299608", "3012267976", "3013497507", "3010034765", "3010273872", "3005180920", "3001236812", "3013846070", "1219518", "3031564283", "3013299874", "3010287687", "1220246", "3010041511", "3012102437", "3003139373", "3014334038", "3005575604", "3546", "3002806315", "1421101", "1000114185", "1017294", "1219602", "3007319107", "3002786339", "3007663067", "3002807830", "3003604053", "1000120613", "3045853999", "1825034", "3004215117", "3003058448", "3030535035", "3038503932", "3010667733", "3002808264", "3026133770", "1020279", "3004216008", "1000115048", "1000402972", "3009513193", "3033536312", "3008812560", "3009971621", "1000115331", "3006981798", "3008770252", "1643264", "1043534", "1000123971", "1824313", "3000215205", "3043620689", "3006509795", "2183449", "3019269298" ], "device_name": "Passer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.4540", "device_class": "1" } } ] }