{ "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": "124777", "product_res_number": "Z-0784-2014", "event_date_initiated": "2013-12-19", "event_date_posted": "2014-01-17", "recall_status": "Terminated", "event_date_terminated": "2015-02-24", "res_event_number": "66846", "product_code": "KRO", "k_numbers": [ "K070978" ], "product_description": "Zimmer Segmental Systems; Polyethylene Inserts, Size C.\r\n\r\nKnee replacement.", "code_info": "Part numbers 00-5850-013-95", "firm_fei_number": "1000220733", "recalling_firm": "Zimmer, Inc.", "address_1": "345 E Main St", "city": "Warsaw", "state": "IN", "postal_code": "46580-2746", "additional_info_contact": "800-613-6131", "reason_for_recall": "After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.", "root_cause_description": "Device Design", "action": "Depth of recall\r\n\r\n\" Notifications were sent to customers, surgeons and risk managers, which use the affected product. Distributors were also informed of the notifications sent to surgeons and risk managers. The customers were identified by performing an invoice search and distribution history for the Polyethylene Inserts (00-5850-012-95 and 00-5850-013-95) since product launch. \r\n\r\nRecall Communication\r\n\r\n\" All distributors were notified via electronic mail. Distributors that have received affected inventory were also notified via courier. Hospital risk managers and surgeons were also notified via courier.\r\nOn 12/19/13, hospital risk managers and surgeons were provided with a notification identifying the issue and their responsibilities. These responsibilities include ensuring the affected personnel are aware of the contents of the notification. \r\nOn 12/19/13, Distributors were sent a notification identifying the issue and to provide a copy of the notification sent to surgeons and risk managers. The distributors will also be instructed as needed to assist with identifying a comprehensive list of surgeons. \r\n\r\n\" Communications outside of the United States will occur approximately two weeks after the United States communications.\r\n\r\nEffectiveness Checks\r\n\r\nZimmer will conduct effectiveness checks in the following way:\r\n\r\n\"Surgeons/Hospitals\r\no100% of the FedEx notifications will be accounted for.\r\noSecond and third notification attempts will be made.\r\noFailed delivery attempts following the third attempt will result in the account being deemed as nonresponsive.", "product_quantity": "5305 distribution events", "distribution_pattern": "Worldwide Distribution. USA nationwide and Germany, with further distribution into EU countries.", "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" } } ] }