TemporaryFDAOngoing
Can make you unwell for a while. Do not eat it.
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Check your package for
LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014
- Why
- 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.
- Distributed
- US Nationwide distribution in the states of TX, CA.
- Company
- Innovasis, Inc
- Announced
- Recall began