Innovasis, Inc: Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Read the official notice at FDA (device) →
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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