Anti-Torque Instrument in Vector Pedicle Screw System Recalled
Innovasis, Inc is recalling 5 Anti-Torque instruments (part LS-749) in the Vector Pedicle Screw System due to an undersized condition that may prevent proper engagement during spinal surgery, causing delays.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device where the hazard (undersized component causing surgical delay) has not resulted in reported injuries. Per the rubric, risk-of-harm products where injury has not yet been reported qualify for a score of 3 (High).
Plain-English summary
Innovasis, Inc is recalling 5 Anti-Torque instruments, part LS-749, which are components of the Vector Pedicle Screw System. This system is intended to provide immobilization and stabilization of spinal segments as an adjunct to thoracic, lumbar, and sacral spine fusion procedures.
The recall is due to an undersized condition in the anti-torque instrument that could prevent the mating tip from engaging with the pedicle screw tulip and rod during tightening. This may lead to surgical delay or require intervention and alternative methods to perform the final tightening step.
The affected units are identified by serial numbers 002, 003, 007, 012, and 014, with UDI-DI codes M711BTA2020 and M711LS7490. Distribution was nationwide in the United States, specifically in the states of Texas and California.
Healthcare facilities and surgical teams using the Vector Pedicle Screw System should contact Innovasis, Inc regarding the recalled Anti-Torque instruments and arrange for replacement or alternative instrumentation as needed.
The recalled product
- Product
- Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
- Manufacturer
- Innovasis, Inc
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- LS-749: UDI-DI: M711BTA2020
- M711LS7490
- Serial Numbers: 002
- 003
- 007
- 012
- 014
Distribution
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