{ "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": "142310", "product_res_number": "Z-0472-2016", "event_date_initiated": "2015-12-02", "event_date_created": "2015-12-23", "recall_status": "Terminated", "event_date_terminated": "2016-10-27", "res_event_number": "72829", "product_code": "HWQ", "product_description": "Green Mamba Suture Passer", "code_info": "Catalog Number: 110010850 Lot Number Identification: 167890, 231120, 253210, 550050, 551580, 716300, 953230", "firm_fei_number": "1825034", "recalling_firm": "Biomet, Inc.", "address_1": "56 E Bell Dr", "city": "Warsaw", "state": "IN", "postal_code": "46582-6989", "additional_info_contact": "Audrey Daenzer\n574-372-1570", "reason_for_recall": "There may be a separation\nand an insufficient weld between the spring and washer. The weld between the spring and washer may fracture,\ncausing the Mamba Suture Passer instruments jaw to not actuate properly.\n6 complaints have been received in which 3 have been reported with a delay up to 10 minutes.", "root_cause_description": "Nonconforming Material/Component", "action": "On 12/2/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors and hospital risk managers via courier with instructions to locate and return the affected products. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.", "product_quantity": "13", "distribution_pattern": "FL, NJ, WI, UT, TX, KY, KS, OH, GA, LA, AL, NY, NC, AR, MO, VA, CA, MN, IN, HI", "openfda": { "k_number": [ "K811679", "K843592", "K923381", "K885311", "K791960", "K920621", "K970360", "K841622", "K841623" ], "registration_number": [ "3002808227", "3002579136", "3014334038", "3010635845", "3019269298", "3015974593", "2953359", "3012358417", "3006981798", "3043620689", "3007507973", "1220477", "3004215117", "1421879", "2032098", "9613926", "3011302692", "1825034", "1219518", "3007366790", "2249529", "3009971621", "3012102437", "8010099", "3003418325", "8010372", "2950160", "3006846753", "3005528784", "3013756169", "1835998", "3010060157", "3006524618", "3033536312", "1421101", "8040278", "2011171", "3008747271", "1043534", "9610612", "3010303097", "1054811", "1221051", "3008770252", "1056350", "3031564283", "3014023545", "3011295718", "3034532468", "3008837339", "3005180920", "3026133770", "3038503932", "2936485", "8010177", "3010667733", "1017294", "3011061237", "3013497507", "3009255580", "3007663067", "2183456", "3020584246", "3005067367", "3030535035", "3003139373", "1526534", "3013846070", "3002907620", "3005575604", "3010041511", "3006460162", "3014302784", "2031009", "9615004", "1226230", "3045853999", "3007738736", "3011137372", "1064017", "3020704423", "1822565", "3003604053", "3009540749", "1020279", "1833824", "2916714", "1061927", "2183449", "1319639", "3021477808", "3010659131", "9611278", "3004608878", "1417592", "3006513362", "9613910", "3010536692", "3005809810", "3008792120", "3010047454", "3002807315", "3012267976", "3032391", "3010287687", "1836161", "3009513193", "9611112", "1222928", "1824313", "3042255021", "3008110533", "3000931034", "3012448339", "8044102", "8043971", "8031020", "3003694247", "8030607", "3010331645", "3008812560", "3010273872", "3007319107", "2031917", "1219602", "3004983210", "1649390", "3012130008", "1220246", "1643264", "8044098" ], "fei_number": [ "3002808227", "3002579136", "3014334038", "3013299874", "3010635845", "3019269298", "3015974593", "3012358417", "3006981798", "3043620689", "1220477", "3004215117", "3007282753", "3011302692", "1825034", "1219518", "3009971621", "3012102437", "3000718467", "3003418325", "3006846753", "3005528784", "3013756169", "3010060157", "3002750084", "5870", "1000115331", "3033536312", "1421101", "2011171", "1000140363", "3002808264", "3008747271", "1043534", "3010303097", "3007290840", "3004028763", "3002299608", "3002786339", "1000138054", "1221051", "3008770252", "3546", "3031564283", "3014023545", "3011295718", "3034532468", "3008837339", "3005180920", "3026133770", "3038503932", "2936485", "3000215205", "3010667733", "1000114185", "1017294", "3004574120", "1000518604", "3011061237", "3013497507", "3009255580", "3007663067", "1000272060", "3008782585", "2183456", "3020584246", "3010813691", "3030535035", "3003139373", "1000115048", "1526534", "3013846070", "3002907620", "3005575604", "3010041511", "1000123971", "3006460162", "3014302784", "3010034765", "3045853999", "3007738736", "3020704423", "3003604053", "3000190635", "3009540749", "1020279", "1000120613", "2916714", "3000203000", "2183449", "3001236812", "3021477808", "3010659131", "1000402972", "3004608878", "1417592", "3006513362", "3010536692", "3005809810", "3008792120", "3002821504", "3010047454", "3002807315", "3012267976", "3003058448", "3006509795", "3010287687", "3009513193", "3002806315", "3042255021", "1824313", "3008110533", "3000931034", "3002836339", "3012448339", "3002929183", "3003694247", "3010331645", "3008812560", "3010273872", "3007319107", "1219602", "3005747797", "1000220733", "3004983210", "3001130644", "3004216008", "3012130008", "1220246", "1643264", "3002807830" ], "device_name": "Passer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.4540", "device_class": "1" } } ] }