{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "197587", "product_res_number": "Z-1133-2023", "event_date_initiated": "2022-11-14", "event_date_posted": "2023-02-13", "recall_status": "Open, Classified", "res_event_number": "91376", "product_code": "OIY", "product_description": "iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE", "code_info": "UDI-DI 00810933030582\n\nLot D221301", "firm_fei_number": "3009844603", "recalling_firm": "Conformis, Inc.", "address_1": "600 Technology Park Dr Ste 3 600 Technology Park Dr", "address_2": "Ste 3", "city": "Billerica", "state": "MA", "postal_code": "01821-4154", "additional_info_contact": "Denise Pedulla\n781-345-9001", "reason_for_recall": "Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.", "root_cause_description": "Process control", "action": "On November 14, 2022, the firm sent an Instrument care reminder to field reps, which included an Instrument handling and care reminder.\n\nThe firm sent additional letters and emails to affected consignees starting January 17, 2023. Consignees were instructed to inspect their inventory for product from the affected lot. Immediately cease use of affected product and contact customer service if a field representative has not already reached out to you. Conformis will have a field representative come onsite to inspect, apply Loctite, and review techniques for inspecting the instrument.\n\nCustomers were informed they may continue to use impactor handles from other lots. However, they should ensure they are properly connecting the impactor handle to the keel punch (Refer to surgical technique guide).", "product_quantity": "70", "distribution_pattern": "US Nationwide distribution in the states of AL, AZ, CO, FL, GA, KS, KY, LA, MA, MD, MS, NE, NH, NV, NY, OH, TN, WI, WY.", "openfda": { "k_number": [ "K113756", "K201347", "K100048", "K091956", "K242665", "K111433", "K103756", "K252887", "K103223", "K101433", "K121727", "K120038" ], "registration_number": [ "1720929", "3009888740", "3014763043", "1822565", "3010468876", "3004196040", "3011724582", "1020279", "3009882462", "1649518", "1721676", "3042508254", "3003541440", "3012725451", "3015978338", "3003477135", "1828464", "3004142400", "3016851379", "3010155661", "9614209", "3017410889", "3014833750", "3003998208", "3010331645", "3030412764", "3036756245", "3015259876", "3010287685", "3011683674", "9613369", "1221053", "1219655", "3007923096", "3009848551", "1424263", "3010287737", "1835251", "3015398319", "3010057495", "3005360851", "1828288", "3011015572", "3012275107", "1644408", "3005718816", "2249697", "2183744", "3012392319", "3007963827", "3009813841", "3007516837", "3010375065", "3005751028", "3015542154", "3025603301", "3009555440", "3008544874", "2528981", "2183946", "3012319330", "1423662", "3005144609", "3033509898", "1529009", "8043792", "3008824097", "2648920", "3016470314", "1531174", "3008262872", "1832228", "3009241418", "3048147961", "3004153896", "1064858", "1834331", "3010120104", "3006356043", "3004748528", "3042172882", "1835572", "3035366890", "3000264985", "3004153240", "3007366790", "1220477", "1226544", "3004371426", "1645151", "3015806723", "1825034", "3010178296", "1057425", "1526534", "3026776", "1319660", "1450662", "3009555447", "3010173425", "3008868758", "3010009693", "3020703621", "9613350", "3009760038", "3015916578", "1646498", "9681642", "3022142628", "3010220595", "3009887475", "3005061536", "9616671", "3014644608", "3009656988", "3002807314", "3008812251", "2246552", "3015231789", "3013055499", "1220246", "3015516266", "1038671", "3014162916", "3015207155", "3006017180", "1818910", "2244478", "3002808022", "3012329926", "3007539489", "1000200989", "3010531069", "3002807310", "3014302784", "3020745236", "2030624", "3013176080", "1722511", "3020155054", "3010386387", "3006801265", "1061927", "3019767615", "2032521" ], "fei_number": [ "1000116912", "1720929", "3009888740", "3014763043", "3000203000", "3004196040", "3011724582", "1020279", "3009882462", "1000118610", "1721676", "3042508254", "3003070421", "3008397795", "3003541440", "3012725451", "3015978338", "3003477135", "1828464", "3004142400", "3016851379", "3010155661", "3003110073", "3014833750", "3003998208", "3010331645", "3030412764", "3036756245", "3015259876", "3010287685", "3011683674", "1221053", "1219655", "3007923096", "3009848551", "3010287737", "3010057495", "3005360851", "3001236277", "1828288", "3001452082", "3011015572", "3012275107", "3005718816", "2183744", "3002808293", "3012392319", "3007963827", "3009813841", "3007516837", "3010375065", "3005751028", "3015542154", "3025603301", "3009555440", "3008544874", "2528981", "3012319330", "3003574398", "3002854251", "3005144609", "3000215273", "3033509898", "3008824097", "3002806725", "3002808269", "3016470314", "1000116116", "3008262872", "1832228", "3009241418", "3048147961", "3000206435", "3004153896", "1000143502", "3007282753", "1000221916", "3010120104", "3006356043", "3003386935", "3004748528", "3042172882", "3035366890", "3000264985", "1000136478", "3005601732", "3004153240", "1220477", "1000306340", "3015806723", "1825034", "1526534", "1450662", "1000220733", "3009555447", "3008868758", "3010009693", "3020703621", "1000132037", "1000149660", "3003015552", "3002807893", "3009760038", "3015916578", "3002807036", "3002993297", "3022142628", "3010220595", "3009887475", "3005233524", "3005061536", "3000205591", "3009656988", "3014644608", "3002807314", "2246552", "3015231789", "3013055499", "1038671", "3015516266", "3014162916", "3015207155", "3005985723", "1000136269", "3006017180", "1818910", "3002808022", "3012329926", "3007539489", "1000200989", "3010531069", "3002807310", "3014302784", "3007932279", "3020745236", "3003128516", "3013176080", "1000135253", "3020155054", "1000395711", "3010386387", "3006801265", "1220246", "3019767615", "1000138247" ], "device_name": "Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3560", "device_class": "2" } } ] }