{ "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": "196731", "product_res_number": "Z-0276-2023", "event_date_initiated": "2022-10-28", "event_date_posted": "2022-11-22", "recall_status": "Open, Classified", "res_event_number": "91102", "product_code": "HRY", "k_numbers": [ "K093552", "K102380" ], "product_description": "EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base", "code_info": "UDI/DI 0 0192629 08293 9, Lot 1916715", "firm_fei_number": "3010536692", "recalling_firm": "MicroPort Orthopedics Inc.", "address_1": "5677 Airline Rd", "city": "Arlington", "state": "TN", "postal_code": "38002-9501", "additional_info_contact": "901-867-9971", "reason_for_recall": "One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.", "root_cause_description": "Nonconforming Material/Component", "action": "MicroPort Orthopedics Disseminated Urgent Field Safety Notices to its consignees on October 28, 2022 via email. The notices explained the issue, the risk, and requested the following: \n\"ACTIONS TO BE TAKEN BY THE USER:\nOur records indicate that you did receive the above referenced product:\n- Immediately check inventory and quarantine all subject products\n- COMPLETE AND RETURN the attached FSCA Acknowledgement\n- Inform MicroPort Orthopedics of any adverse event immediately\n- Return any affected product to MicroPort Orthopedics, please see your local distributor for details\nTRANSMISSION OF THIS NOTICE:\nThis notice needs to be passed on to all those who need to be aware within your organization.\nCONTACT REFERENCE PERSON:\nFor questions or additional information please contact:\nMicroPort Scientific Coperatief U.A.\nPhone: +31 20 545 01 00\nEmail: PostMarket@ortho.microport.com\"", "product_quantity": "22 units", "distribution_pattern": "International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.", "openfda": { "k_number": [ "K081293", "K810230", "K983657", "K810060", "K820030", "K042093", "K011795", "K760334", "K072704", "K193549", "K834298", "K061681", "K760744", "K780299", "K033351", "K152631", "K010810", "K790762", "K021621", "K012800", "K012591", "K954481", "K011138", "K940389", "K133940", "K100973", "K810540", "K790350", "K792619", "K821341", "K862125", "K030446", "K063515", "K960617", "K961900", "K980665", "K022437", "K001451", "K012762", "K070267", "K060412", "K842367", "K790348", "K082567", "K011509", "K820002", "K781608", "K110415", "K760245", "K933935", "K812012", "K810616", "K053299", "K050764", "K911373", "K030193", "K790349", "K982859", "K864070", "K033810", "K831143", "K884837", "K020264", "K860133", "K883969", "K122277", "K910968", "K971938", "K873601", "K032052", "K955778", "K882241", "K761278", "K890044", "K020741", "K000172", "K802446", "K040268", "K131167", "K760842", "K071881", "K974434", "K902538", "K923011", "K040889", "K190633", "K792325", "K051721", "K150410", "K014171", "K944538" ], "pma_number": [ "P840049" ], "registration_number": [ "1038671", "1644408", "1220477", "3007539489", "3013055499", "2244478", "3008021110", "3005718816", "3014302784", "3002807310", "1649518", "3017410889", "3007200272", "3015542154", "3013014058", "1450662", "2242737", "9610612", "3003639920", "1000517406", "3010173425", "3002806470", "1833506", "3008658204", "3006356043", "3020745236", "3011295718", "3011061242", "2249697", "3002907620", "3033509898", "1828464", "2245304", "3013791180", "3006017180", "1226544", "1054811", "3011683674", "1721676", "3010536692", "3020703621", "3009241418", "3009555447", "3015207155", "1834331", "3003387384", "3003998208", "1423662", "3010047402", "3010288357", "3004748528", "1529009", "3005706667", "3016438694", "3016090213", "3010097171", "3021008900", "1057425", "9616671", "3008868758", "3006015326", "3007311878", "3009973336", "1064858", "3004641308", "1526534", "9614209", "3013176080", "3009475821", "3002808022", "3006801265", "2133928", "8010916", "1833920", "9681465", "3009555440", "9610726", "3008395353", "3010220595", "3015516266", "1822565", "2183744", "3009973505", "1421101", "3017397663", "1219602", "1047843", "3005061536", "3010039400", "1825034", "3038503932", "1827096", "1000550978", "9616680", "1219655", "8010379", "3012725451", "3009882462", "3006395932", "1319660", "2134285", "1020279", "3007366790", "2249615", "3002806603", "1061927", "3010041693", "3004371426", "3003477135", "3009546990", "3015916578", "3009888740", "3025603301", "3011274144", "3036756245", "3014315669", "3027484613", "3007923096", "1643264", "1818910", "3035366890", "3014662844", "3026771806", "3009848551" ], "fei_number": [ "3005985723", "1038671", "3001236277", "1220477", "3003569173", "3007539489", "3013055499", "3008021110", "3005718816", "3014302784", "3002807310", "3007282753", "3015542154", "3007200272", "3013014058", "1450662", "3003639920", "1000220733", "1000517406", "3002807172", "3002806470", "1000149660", "3001548076", "3008658204", "3006356043", "3020745236", "3011295718", "3011061242", "1832656", "3002907620", "3033509898", "1828464", "2245304", "3013791180", "3006017180", "3011683674", "1721676", "3010536692", "3020703621", "3009241418", "3009555447", "3015207155", "3003387384", "3003998208", "3000203000", "3010047402", "3000215273", "3010288357", "3004748528", "1000221916", "3005706667", "3016438694", "3016090213", "3010097171", "3021008900", "3008397795", "3003070421", "3001049282", "3008868758", "3006015326", "3007311878", "3009973336", "3004641308", "1526534", "3013176080", "3009475821", "3002808022", "1000306340", "3006801265", "3009555440", "3003128516", "1000136478", "3008395353", "3010220595", "3015516266", "2183744", "3009973505", "3002806315", "1421101", "1000114185", "3017397663", "1219602", "1047843", "3005061536", "3002287318", "1000115656", "3010039400", "3002854251", "1825034", "3038503932", "1827096", "1000550978", "1219655", "3012725451", "3002459190", "3009882462", "3006395932", "1020279", "3002806603", "3002807036", "3002807113", "1000199976", "3010041693", "3003477135", "3009546990", "3015916578", "3009888740", "3025603301", "3003386935", "3011274144", "3036756245", "3014315669", "3027484613", "3007923096", "3000717902", "1643264", "1000116912", "1000136269", "1818910", "3002806725", "3035366890", "3014662844", "3026771806", "3009848551" ], "device_name": "Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3530", "device_class": "2" } } ] }