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Innovasis, Inc: Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System

Medical DevicesSource: FDA (device) · Date: 2026-08-12

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Innovasis, Inc
Product
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of TX, CA.
Recall initiated
2026-05-22
Code info
LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014
Product quantity
5
Voluntary mandated
Voluntary: Firm initiated
City
Salt Lake City
State
UT
Country
United States
Event id
99188
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