{"recall":{"id":"fda-device-99868","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"SI-BONE, Inc. recalls iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm)","firm":"SI-BONE, Inc.","date":"2026-08-21","reported":"2026-10-21","status":"Ongoing","classification":"Class II","products":[{"name":"iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)","code":"10055T-UDI:00810055520077/Lot:9142871 10060T-UDI:00810055520084/Lot:9137761 10065T-UDI:00810055520091/Lot:9139213 10080T-UDI:00810055520121/Lot:9137781 11580T-UDI:00810055520367/Lot:9142911","quantity":"100 units","number":"Z-0146-2027","classification":"Class II"}],"reason":"The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.","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":"100 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=99868","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"794b168790fa1d3d","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=99868","record":[{"status":"Ongoing","city":"Santa Clara","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99868","recalling_firm":"SI-BONE, Inc.","address_1":"471 El Camino Real Ste 101","address_2":"","postal_code":"95050-4482","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.","recall_number":"Z-0146-2027","product_description":"iFuse TORQ Implant System  Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)","product_quantity":"100 units","reason_for_recall":"The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.","recall_initiation_date":"20260821","center_classification_date":"20261009","report_date":"20261021","code_info":"10055T-UDI:00810055520077/Lot:9142871 10060T-UDI:00810055520084/Lot:9137761 10065T-UDI:00810055520091/Lot:9139213 10080T-UDI:00810055520121/Lot:9137781 11580T-UDI:00810055520367/Lot:9142911","more_code_info":""}]}}