United StatesAnti-Torque (Vector) Part LS-749, part of the Vector Pedicle Screw System (UDI-DI: M711BTA2020, M711LS7490; serial numbers 002, 003, 007, 012, 014), distributed in the United States (TX, CA), is being recalled by Innovasis, Inc. The anti-torque instrument may be undersized and fail to engage the pedicle screw tulip and rod during tightening, which could cause surgical delay or require alternative methods to complete the final tightening step.
What's being recalled
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Recalling firm: Innovasis, Inc, Salt Lake City, UT, United States.
How to identify it
LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of TX, CA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)