{"recall":{"id":"fda-device-99651","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Wright Medical Technology, Inc. recalls CHARLOTTE CLAW Screw","firm":"Wright Medical Technology, Inc.","date":"2026-08-18","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System","code":"UDI-DI: 00840420109705, Lot: 1826666, Distributed: 18-Aug-2025 through 09-Apr-2026","quantity":"34","number":"Z-3334-2026","classification":"Class II"}],"reason":"Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the plate's internal threads, which may lead to surgery prolongation to retrieve another device, or alternative surgery method if no replacement device is readily available.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN, NJ, WI, CO.","nationwide":true,"states":[],"units":"34","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=99651","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"bbf409019d064422","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=99651","record":[{"status":"Ongoing","city":"arlington","state":"TN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99651","recalling_firm":"Wright Medical Technology, Inc.","address_1":"11500 memphis arlington rd","address_2":"","postal_code":"38117-5423","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN, NJ, WI, CO.","recall_number":"Z-3334-2026","product_description":"CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System","product_quantity":"34","reason_for_recall":"Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the plate's internal threads, which may lead to surgery prolongation to retrieve another device, or alternative surgery method if no replacement device is readily available.","recall_initiation_date":"20260818","center_classification_date":"20260930","report_date":"20261007","code_info":"UDI-DI: 00840420109705, Lot: 1826666, Distributed: 18-Aug-2025 through 09-Apr-2026","more_code_info":""}]}}