{ "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": "140223", "product_res_number": "Z-0165-2016", "event_date_initiated": "2015-09-16", "event_date_posted": "2015-10-26", "recall_status": "Terminated", "event_date_terminated": "2016-01-04", "res_event_number": "72216", "product_code": "OIY", "k_numbers": [ "K140830" ], "product_description": "Exprt Precision System: Revision Knee, Model Number 160-010-726/738\r\n\r\nFor use with the Exprt Knee System in total knee arthroplasty to replace the native patella.", "code_info": "471T1-001/011; 472T1-000/014; 473T1-000/015; 474T1-000/010; 475T1-000/008", "firm_fei_number": "1000116912", "recalling_firm": "Encore Medical, Lp", "address_1": "9800 Metric Blvd", "city": "Austin", "state": "TX", "postal_code": "78758-5445", "additional_info_contact": "Desiree Wells\n512-832-6302", "reason_for_recall": "The labeling is missing the size/diameter information.", "root_cause_description": "Labeling design", "action": "DJO Surgical sent an Urgent Field Safety Notice dated September 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\r\n\r\nThe letter requested the consignees complete and return a response card and return affected devices for replacement. For further questions call (512) 832-6302.", "product_quantity": "209 units", "distribution_pattern": "US Distribution to the states of : SC, WI, RI, NY, MO, AR, OK, GA, FL, AL, CA, AZ and CO.", "openfda": { "k_number": [ "K100048", "K121727", "K101433", "K242665", "K103223", "K103756", "K111433", "K252887", "K091956", "K113756", "K201347", "K120038" ], "registration_number": [ "3010331645", "", "1038671", "3008812251", "3014833750", "3008544874", "1644408", "3020155054", "1220477", "3007539489", "3013055499", "2244478", "3005718816", "3014302784", "3002807310", "1649518", "3017410889", "3015542154", "1450662", "3014162916", "3005144609", "2030624", "3016470314", "3010173425", "3010287685", "3010531069", "9613369", "1531174", "2528981", "3006356043", "3020745236", "3011724582", "3009887475", "2249697", "3033509898", "1720929", "1828464", "3015806723", "3006017180", "1226544", "3002807314", "1835251", "1645151", "3011683674", "1721676", "1722511", "3020703621", "3009241418", "3004196040", "3009555447", "3015207155", "1834331", "3003998208", "1646498", "1423662", "3010386387", "3042172882", "3026776", "3004153240", "3010375065", "3010009693", "3004748528", "1529009", "3007963827", "3008262872", "1221053", "3030412764", "1057425", "8043792", "3008824097", "2648920", "9616671", "3015231789", "3008868758", "3012275107", "1064858", "3004153896", "1526534", "9614209", "9681642", "3013176080", "2183946", "3002808022", "3010057495", "3006801265", "1220246", "3009555440", "3011015572", "3010220595", "3014644608", "3015516266", "3042508254", "1822565", "2183744", "3015259876", "2246552", "3005061536", "3009760038", "3019767615", "1825034", "1424263", "3009813841", "1832228", "3010468876", "1219655", "3005751028", "3010155661", "3014763043", "3012725451", "3000264985", "3015398319", "2032521", "3009882462", "3007516837", "1835572", "1319660", "1020279", "3012392319", "3007366790", "3005360851", "3010120104", "3012319330", "3010178296", "3010287737", "3003541440", "3004142400", "1061927", "3004371426", "3003477135", "3012329926", "3015916578", "3009888740", "3025603301", "3036756245", "3016851379", "1000200989", "3022142628", "3007923096", "1828288", "3009656988", "1818910", "3035366890", "9613350", "3009848551" ], "fei_number": [ "3010331645", "", "3005985723", "1038671", "3001236277", "3014833750", "3008544874", "3020155054", "1220477", "3003015552", "3007539489", "3013055499", "3005718816", "3014302784", "3002807310", "3007282753", "3015542154", "1450662", "3014162916", "1000220733", "3005144609", "1000395711", "3016470314", "3010287685", "3010531069", "1000149660", "2528981", "3006356043", "3020745236", "3007932279", "3011724582", "3005233524", "3009887475", "3033509898", "1720929", "1828464", "3015806723", "3005601732", "3006017180", "3002807314", "3011683674", "3002993297", "1721676", "1000118610", "1000135253", "3020703621", "3009241418", "3004196040", "3009555447", "3015207155", "3003998208", "3010386387", "3042172882", "3001452082", "3004153240", "3010375065", "3010009693", "3000203000", "3000215273", "3004748528", "1000221916", "3007963827", "3008262872", "1221053", "3030412764", "3008824097", "3008397795", "3003070421", "3002808293", "3015231789", "3008868758", "1000116116", "3012275107", "3004153896", "1526534", "1000143502", "3013176080", "3002808022", "3010057495", "1000306340", "3006801265", "3003574398", "3000205591", "1220246", "3009555440", "3003128516", "1000136478", "3011015572", "3010220595", "3014644608", "3015516266", "3042508254", "2183744", "3015259876", "2246552", "3005061536", "3009760038", "3019767615", "1000138247", "3002808269", "3002854251", "1825034", "3009813841", "3002807893", "1832228", "1219655", "3005751028", "3010155661", "3014763043", "3012725451", "3000264985", "3009882462", "3007516837", "1020279", "3012392319", "3005360851", "3010120104", "3012319330", "3010287737", "3003541440", "3002807036", "3004142400", "3003477135", "3012329926", "3015916578", "3009888740", "3025603301", "3003386935", "3036756245", "3016851379", "1000200989", "3022142628", "3007923096", "1828288", "1000116912", "3009656988", "1000136269", "1818910", "3002806725", "3035366890", "1000132037", "3000206435", "3003110073", "3009848551" ], "device_name": "Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3560", "device_class": "2" } } ] }