{"recall":{"id":"fda-device-99188","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Innovasis, Inc recalls Anti-Torque","firm":"Innovasis, Inc","date":"2026-05-22","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System","code":"LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014","quantity":"5","number":"Z-2859-2026","classification":"Class II"}],"reason":"Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of TX, CA.","nationwide":true,"states":[],"units":"5","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=99188","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"48cf69d0a3f7f5fc","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=99188","record":[{"status":"Ongoing","city":"Salt Lake City","state":"UT","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99188","recalling_firm":"Innovasis, Inc","address_1":"614 E 3900 S","address_2":"","postal_code":"84107-1902","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of TX, CA.","recall_number":"Z-2859-2026","product_description":"Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System","product_quantity":"5","reason_for_recall":"Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step.","recall_initiation_date":"20260522","center_classification_date":"20260803","report_date":"20260812","code_info":"LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007,  012, 014","more_code_info":""}]}}