{"recall":{"id":"fda-device-99512","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"restor3d Inc. recalls Kinos Axiom Total Ankle System with Axiom PSR","firm":"restor3d Inc.","date":"2026-07-27","reported":"2026-09-23","status":"Ongoing","classification":"Class II","products":[{"name":"Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006","code":"System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.","quantity":"2","number":"Z-3178-2026","classification":"Class II"}],"reason":"Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of FL, CO.","nationwide":true,"states":[],"units":"2","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99512","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"ac5407146de61cd0","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99512","record":[{"status":"Ongoing","city":"Durham","state":"NC","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99512","recalling_firm":"restor3d Inc.","address_1":"4001 E Nc 54 Hwy","address_2":"Suite 3160","postal_code":"27709","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of FL, CO.","recall_number":"Z-3178-2026","product_description":"Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006","product_quantity":"2","reason_for_recall":"Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery.","recall_initiation_date":"20260727","center_classification_date":"20260916","report_date":"20260923","code_info":"System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.","more_code_info":""}]}}