{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "136166", "product_res_number": "Z-0275-2016", "event_date_initiated": "2015-04-17", "event_date_posted": "2015-11-14", "recall_status": "Terminated", "event_date_terminated": "2017-01-05", "res_event_number": "71121", "product_code": "KRO", "k_numbers": [ "K130299" ], "product_description": "GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery", "code_info": "Lot: 145129", "firm_fei_number": "3015500078", "recalling_firm": "Medacta Usa", "address_1": "1556 W Carroll Ave", "city": "Chicago", "state": "IL", "postal_code": "60607-1012", "additional_info_contact": "Mr. Mike Loiterman\n312-548-9971", "reason_for_recall": "Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.", "root_cause_description": "Employee error", "action": "On 4/16/15 all distributors with recalled product were immediately notified of the recall by phone. On 4/20/15, all distributors were further notified of the recall via email. The URGENT MEDICAL DEVICE RECALL letter dated 4/17/2015 the firm described the initiation of a recall for regarding the GMK HINGE Tibial Augmentation Size 4-10mm Reference 02.09TA410 / Lot 145129.\n\n\nThe firm provided the following recall actions to be performed:\n\n1.Check your inventory for the device listed above. If you find it, IMMEDIATELY place it in quarantine and DO NOT use it in surgery.\n2.If you have further distributed this device to other customers please notify me and initiate their return to Medacta USA.\n3.We will provide you with an update on a replacement within the next few days.\n\nThe firm also provided a contact for customers requiring additional information.\n\nMike Loiterman Director of Regulatory, Quality and Compliance Medacta USA Phone: 312548-9971Fax: 312-546-6881MLoiterman@medacta.us.com", "product_quantity": "4 units (US)", "distribution_pattern": "Distributed in the states of IL, OH and UT, and the countries of in Austria, Spain, Australia, France and Switzerland.", "openfda": { "k_number": [ "K223069", "K021714", "K820995", "K781971", "K140900", "K192798", "K233980", "K896048", "K242871", "K062301", "K823115", "K252898", "K823420", "K051479", "K013035", "K020381", "K811105", "K910877", "K151118", "K223528", "K252303", "K240043", "K002552", "K151008", "K023087", "K152431", "K211677", "K083827", "K083779", "K140509", "K191779", "K230416", "K261898", "K945028", "K013385", "K230563", "K052685", "K080330", "K821340", "K982160", "K120992", "K021260", "K131393", "K220628", "K172347", "K972401", "K810520", "K122015", "K101815", "K110940", "K081111", "K060131", "K821476", "K994207", "K150028", "K161520", "K070978", "K211768", "K023667", "K910596", "K031480", "K251665", "K133152", "K031804", "K163311", "K041352", "K121029", "K010774", "K210010", "K072367", "K013031", "K001548", "K092138", "K040749", "K143179", "K140898", "K051570", "K021489", "K060360", "K003504", "K190100", "K013340", "K130299", "K190181", "K091453", "K011810", "K001957" ], "registration_number": [ "1020279", "3020703621", "3005551626", "2134285", "3006395932", "3002807315", "1531174", "1822565", "3010097171", "9610612", "3004196040", "3009973505", "1218882", "3013055499", "1423662", "1047843", "3007189546", "3015542154", "2249697", "3006946276", "3003639920", "1828464", "1833920", "3010386387", "1825034", "2133928", "3009882462", "3010065126", "3009760038", "8043792", "1835251", "3012329926", "3000264985", "3007923096", "9681642", "3007856226", "1643264", "1827096", "3009923578", "3009888740", "2648920", "9610726", "3008421730", "3005562917", "3011187779", "3014680795", "9681465", "3009848551", "1225675", "3009813841", "1645151", "3011061242", "3036773273", "3008556682", "3008868758", "1219655", "1833986", "3004748528", "3014302784", "1220477", "1422549", "3005061536", "1000550978", "1450662", "1000517406", "3012725451", "3004513872", "3003387384", "3010009693", "3009973336", "3011015572", "3002808022", "3010041993", "1526534", "3029890418", "3008281151", "3016438694", "3038503932", "3007963827", "3011295718", "2183946", "1834331", "3002907620", "3011683674", "9616944", "3006801265", "1057425", "1721676", "1424263", "3004371426", "1834379", "3009732568", "9616671", "3012755988", "3033509898", "3005180920", "3021008900", "3022142628", "3007366790", "2245304", "1836357", "1818910", "1529009", "3007539489", "9616680", "2249615", "3010057495", "3010163695", "3009173317", "1000200989", "9613369", "3010536692", "9611390", "3010039400", "3004153896", "3010220595", "3004635447", "3001284227", "3010132111", "2246552", "3014252644", "3008110533", "3036756245", "3005751028", "2244478", "3025603301", "3010288357", "3010173425", "3013176080", "3035366890", "9610622", "3006017180", "2528981", "3002807310", "3015207155", "3015516266", "3013450937" ], "fei_number": [ "1020279", "1000116116", "3020703621", "1000118610", "3005551626", "3006395932", "3002807315", "3000717902", "3010097171", "3004196040", "3009973505", "1000221916", "1218882", "3013055499", "1047843", "3007189546", "3015542154", "3006946276", "3003639920", "1828464", "3002806315", "3010386387", "1825034", "3009882462", "3010065126", "3002854251", "3009760038", "1000149660", "3003064967", "3012329926", "3002807036", "3007923096", "3000264985", "1000306340", "3007856226", "3000205591", "3002807172", "1000395711", "1643264", "3007282753", "1827096", "3009923578", "3009888740", "3008421730", "3005562917", "3011187779", "1000220733", "3014680795", "1000159999", "1000136269", "3009848551", "3009813841", "1000115656", "3011061242", "3036773273", "3008556682", "3008868758", "1219655", "3004748528", "1000306303", "3014302784", "1220477", "3005061536", "1000550978", "1450662", "1000517406", "3012725451", "3003414678", "3004513872", "3001049282", "3003387384", "3010009693", "3009973336", "3011015572", "3002808022", "3002808269", "3010041993", "1526534", "3002993297", "3029890418", "3002806773", "3008281151", "3016438694", "3038503932", "3007963827", "3011295718", "3002907620", "3003386935", "3011683674", "3006801265", "3002287318", "1721676", "3002807231", "3000215273", "3009732568", "1000132037", "3012755988", "3033509898", "3005180920", "3021008900", "3001451451", "3022142628", "2245304", "1818910", "3002807893", "3007539489", "1000139987", "3010057495", "3010163695", "3009173317", "1000200989", "3010536692", "3010039400", "3004153896", "3010220595", "3004635447", "3001284227", "3010132111", "2246552", "3014252644", "3008110533", "3036756245", "3005751028", "3003015552", "3025603301", "3010288357", "3002807113", "3013176080", "3035366890", "3003070421", "3002459190", "3006017180", "2528981", "3002807310", "3015207155", "3015516266", "3013450937" ], "device_name": "Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3510", "device_class": "2" } } ] }