{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221502", "product_res_number": "Z-2934-2026", "event_date_initiated": "2026-07-06", "event_date_posted": "2026-08-11", "recall_status": "Open, Classified", "res_event_number": "99405", "product_code": "KRO", "k_numbers": [ "K143179" ], "product_description": "Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge\nItem Number 15-0027/16", "code_info": "UDI-DI 04026575432134\nLot for Implant REF 15-0027/16: 2604069", "firm_fei_number": "3003386935", "recalling_firm": "Waldemar Link GmbH & Co. KG (Mfg Site)", "address_1": "Ost Str. 4-10 4-10 ost str.", "city": "Norderstedt", "country": "Germany", "additional_info_contact": "Terry Sheridan Powell\n494053995150", "reason_for_recall": "The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.", "root_cause_description": "Process change control", "action": "Foreign manufacturer, Waldemar Link GmbH & Co KG, notified importer LinkBio Corp. on 7/6/2026 via email. LinkBio then notified the single US consignee by email/Docusign on 7/7/2026.\n\nCustomer was instructed to return the affected product to LinkBio.", "product_quantity": "1 US; 9 OUS", "distribution_pattern": "Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.", "openfda": { "k_number": [ "K781971", "K261898", "K031804", "K131393", "K140900", "K120992", "K191779", "K072367", "K083779", "K013031", "K240043", "K821340", "K031480", "K211677", "K140509", "K013385", "K130299", "K013035", "K823420", "K220628", "K021714", "K080330", "K910596", "K003504", "K233980", "K060360", "K010774", "K811105", "K052685", "K081111", "K223528", "K023087", "K151008", "K150028", "K070978", "K002552", "K110940", "K020381", "K101815", "K210010", "K252898", "K910877", "K211768", "K121029", "K051479", "K172347", "K013340", "K143179", "K133152", "K091453", "K041352", "K810520", "K223069", "K982160", "K151118", "K242871", "K190181", "K021489", "K092138", "K060131", "K192798", "K163311", "K122015", "K001548", "K011810", "K821476", "K251665", "K252303", "K994207", "K896048", "K230563", "K083827", "K161520", "K140898", "K823115", "K051570", "K230416", "K062301", "K152431", "K040749", "K023667", "K001957", "K945028", "K021260", "K820995", "K972401", "K190100" ], "registration_number": [ "3009973505", "2133928", "3010009693", "9613369", "1645151", "2245304", "9610612", "3008110533", "3006395932", "3008281151", "3003387384", "9681642", "1000550978", "3007963827", "1828464", "3036756245", "1833920", "3007366790", "3012755988", "3009732568", "3015516266", "1835251", "3003639920", "3014302784", "3005061536", "1833986", "3010163695", "3005180920", "3038503932", "3008556682", "1218882", "3004371426", "1422549", "3007856226", "3010041993", "1643264", "3011061242", "3010065126", "3007923096", "1822565", "3033509898", "3009923578", "3013055499", "3015542154", "3011187779", "9616944", "3004748528", "3022142628", "3036773273", "2249697", "3009882462", "3014252644", "8043792", "3006801265", "9610726", "3004196040", "9611390", "1529009", "1834379", "3009888740", "1450662", "2648920", "3009973336", "9610622", "3010288357", "3008421730", "3011015572", "3007539489", "9616671", "1020279", "3006946276", "1834331", "3020703621", "3009813841", "3009173317", "3010536692", "3016438694", "2246552", "1220477", "3009848551", "3010132111", "1526534", "3029890418", "2528981", "3006017180", "3005551626", "3008868758", "3002808022", "3014680795", "3013450937", "1721676", "3009760038", "3010173425", "9681465", "3007189546", "3004635447", "1219655", "3025603301", "2244478", "3005751028", "3002907620", "3004153896", "3013176080", "3004513872", "1531174", "3012329926", "3011295718", "2134285", "1836357", "1000517406", "3010220595", "1423662", "9616680", "3002807310", "1818910", "3010039400", "3010386387", "3021008900", "1827096", "1047843", "3001284227", "1057425", "3035366890", "3010057495", "3010097171", "3015207155", "1825034", "1225675", "3002807315", "1000200989", "2249615", "3000264985", "3012725451", "3005562917", "1424263", "3011683674", "2183946" ], "fei_number": [ "3009973505", "3010009693", "1000159999", "2245304", "3008110533", "3006395932", "3008281151", "3003387384", "1000139987", "1000550978", "3007963827", "1828464", "3036756245", "3012755988", "3009732568", "3003064967", "3015516266", "3002806315", "3003639920", "3014302784", "3005061536", "1000132037", "3010163695", "3005180920", "3038503932", "3008556682", "1218882", "3002807893", "1000395711", "3007856226", "3010041993", "1643264", "3002808269", "3011061242", "3010065126", "3007923096", "3033509898", "3009923578", "3000205591", "3003386935", "3013055499", "3015542154", "3011187779", "1000221916", "3004748528", "3002807231", "3022142628", "3036773273", "3009882462", "3014252644", "3006801265", "3004196040", "1000220733", "3002287318", "3002806773", "3009888740", "1450662", "3009973336", "3010288357", "3008421730", "3011015572", "3007539489", "3007282753", "1020279", "3006946276", "3020703621", "3009813841", "3009173317", "3010536692", "3016438694", "2246552", "1220477", "3000717902", "3009848551", "3002807113", "1000306340", "3010132111", "3002807172", "1526534", "3002854251", "1000118610", "2528981", "3029890418", "3006017180", "3005551626", "3008868758", "3002808022", "3014680795", "3013450937", "1721676", "3009760038", "3007189546", "3004635447", "1219655", "3025603301", "3002907620", "3004153896", "3000215273", "3013176080", "3004513872", "3012329926", "3011295718", "1000136269", "1000116116", "1000517406", "3010220595", "3002459190", "3003070421", "3002807310", "1818910", "3002807036", "3010039400", "3010386387", "3003015552", "3021008900", "1827096", "1000115656", "1047843", "3001284227", "3035366890", "3010057495", "3001451451", "3010097171", "1000306303", "3015207155", "3003414678", "1825034", "3002807315", "3002993297", "3001049282", "1000200989", "3000264985", "3012725451", "1000149660", "3005562917", "3011683674", "3005751028" ], "device_name": "Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3510", "device_class": "2" } } ] }