{ "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": "49451", "product_res_number": "Z-0456-2007", "event_date_initiated": "2006-11-15", "event_date_posted": "2007-01-11", "recall_status": "Terminated", "event_date_terminated": "2008-04-30", "res_event_number": "36849", "product_code": "HRY", "k_numbers": [ "K040268" ], "product_description": "Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 1, sterile; Part number 1498-24-001.", "code_info": "All lots.", "firm_fei_number": "1818910", "recalling_firm": "Depuy Orthopaedics, Inc.", "address_1": "700 Orthopaedic Dr", "city": "Warsaw", "state": "IN", "postal_code": "46582-3994", "additional_info_contact": "800-366-8143", "reason_for_recall": "Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.", "root_cause_description": "Other", "action": "The firm's sales force was notified of the recall via email sent 11/15/06. The sales force was instructed to deliver a recall letter to personnel in those facilities that had purchased the products, and the recall letters instruct the facilities to quarantine the product and respond to Depuy concerning product returns. The sales force was provided with a Dear Doctor letter for issuance to implanting surgeons at the sales forces' discretion. The recall was extended to Sizes 1-5 on Dec 5, 2006 with a second recall letter.", "product_quantity": "558 for Recalls Z-0456-0465-2007", "distribution_pattern": "Class II Recall - Worldwide Distribution ---USA and countries of Argentina and Colombia.", "openfda": { "k_number": [ "K082567", "K122277", "K022437", "K790348", "K961900", "K081293", "K982859", "K014171", "K831143", "K790762", "K821341", "K810540", "K820002", "K152631", "K021621", "K063515", "K032052", "K790349", "K810060", "K030446", "K933935", "K012800", "K955778", "K862125", "K923011", "K873601", "K190633", "K812012", "K820030", "K070267", "K760744", "K000172", "K944538", "K792619", "K911373", "K053299", "K011795", "K860133", "K760334", "K954481", "K902538", "K983657", "K040889", "K810230", "K020741", "K193549", "K810616", "K011509", "K060412", "K802446", "K033351", "K834298", "K910968", "K012591", "K110415", "K033810", "K760245", "K864070", "K001451", "K020264", "K040268", "K780299", "K030193", "K890044", "K042093", "K100973", "K960617", "K760842", "K884837", "K792325", "K883969", "K882241", "K790350", "K974434", "K061681", "K131167", "K842367", "K940389", "K072704", "K761278", "K011138", "K010810", "K980665", "K071881", "K133940", "K781608", "K051721", "K050764", "K150410", "K012762", "K971938" ], "pma_number": [ "P840049" ], "registration_number": [ "3020703621", "1000550978", "3007200272", "8010379", "1220477", "3035366890", "3013055499", "3010097171", "3010047402", "1825034", "3007366790", "3006801265", "3005718816", "3002806603", "3021008900", "3007539489", "3003639920", "3005061536", "3003998208", "1421101", "3008395353", "1423662", "2133928", "3015516266", "9610612", "3009848551", "1054811", "2245304", "1319660", "3017397663", "9681465", "3008658204", "1450662", "1219655", "3026771806", "3009888740", "3036756245", "3004371426", "2244478", "3014662844", "3011295718", "3002807310", "3013791180", "3038503932", "3004748528", "3009475821", "3009973336", "3010220595", "3017410889", "1827096", "3006356043", "3009546990", "3013014058", "3011061242", "3025603301", "2249615", "3006017180", "3011683674", "3033509898", "3010288357", "1526534", "3010039400", "3002907620", "3014302784", "1057425", "2134285", "3013176080", "3012725451", "1064858", "9616680", "3008021110", "3020745236", "3009882462", "1834331", "1822565", "3016438694", "1047843", "1020279", "1833920", "3003477135", "1061927", "3002806470", "3007311878", "1649518", "3011274144", "8010916", "1038671", "1833506", "2242737", "1644408", "9614209", "1529009", "3010536692", "3008868758", "3009241418", "3014315669", "3009973505", "3009555447", "9610726", "3003387384", "3007923096", "3009555440", "3015207155", "1721676", "3015542154", "3004641308", "2183744", "9616671", "1219602", "3010173425", "3002808022", "3006015326", "1226544", "3005706667", "3016090213", "1828464", "1000517406", "3015916578", "3027484613", "2249697", "3010041693", "1818910", "1643264", "3006395932" ], "fei_number": [ "3020703621", "1000550978", "3007200272", "1220477", "3035366890", "3008397795", "3013055499", "3007282753", "3010097171", "3010047402", "1825034", "1000116912", "3006801265", "3005718816", "3002806603", "3021008900", "3002807172", "3007539489", "3003639920", "3005061536", "3003998208", "1421101", "3008395353", "3005985723", "3015516266", "1000115656", "3009848551", "3002287318", "3017397663", "2245304", "1000136478", "3008658204", "1450662", "1219655", "3026771806", "3009888740", "3036756245", "3000215273", "3002807113", "3002459190", "3003569173", "3003128516", "3014662844", "3011295718", "3002807310", "3003070421", "3013791180", "3038503932", "3004748528", "3009475821", "3009973336", "3010220595", "1000114185", "1827096", "3006356043", "3003386935", "3009546990", "3013014058", "3011061242", "3025603301", "3006017180", "3011683674", "3033509898", "3010288357", "1526534", "3010039400", "3002907620", "1000306340", "3014302784", "3013176080", "3012725451", "3008021110", "3020745236", "3009882462", "3002854251", "3016438694", "1047843", "1020279", "3003477135", "3000203000", "3002806470", "3007311878", "3011274144", "3002806725", "1038671", "3010536692", "3002807036", "3008868758", "3001236277", "3009241418", "3014315669", "3009973505", "1000149660", "1000199976", "1000221916", "3009555447", "3003387384", "3007923096", "3002806315", "1832656", "3001049282", "1000136269", "3009555440", "3015207155", "1721676", "3015542154", "3004641308", "2183744", "3000717902", "1219602", "3002808022", "3006015326", "1000220733", "3005706667", "3016090213", "1828464", "1000517406", "3015916578", "3027484613", "3010041693", "3001548076", "1818910", "1643264", "3006395932" ], "device_name": "Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3530", "device_class": "2" } } ] }