{"recall":{"id":"fda-device-99846","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"In2bones USA, LLC recalls REF: P65 ST862 CoLag SCREW","firm":"In2bones USA, LLC","date":"2026-09-09","reported":"2026-10-21","status":"Ongoing","classification":"Class II","products":[{"name":"REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm","code":"UDI: 00817906023992/Lot: GM008380; GM007868","quantity":"29 units","number":"Z-0157-2027","classification":"Class II"}],"reason":"Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.","nationwide":true,"states":[],"units":"29 units","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=99846","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"fb0f7381c961f509","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=99846","record":[{"status":"Ongoing","city":"Cordova","state":"TN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99846","recalling_firm":"In2bones USA, LLC","address_1":"7750a Trinity Rd","address_2":"","postal_code":"38018-2722","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.","recall_number":"Z-0157-2027","product_description":"REF: P65 ST862  CoLag SCREW, FT, 6.7X62.5 mm","product_quantity":"29 units","reason_for_recall":"Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.","recall_initiation_date":"20260909","center_classification_date":"20261014","report_date":"20261021","code_info":"UDI: 00817906023992/Lot: GM008380; GM007868","more_code_info":""}]}}