Innovasis Vector anti-torque tool recalled for undersized condition
Innovasis, Inc. is recalling certain Vector anti-torque instruments (part LS-749) used with the Vector Pedicle Screw System for spinal fusion. The instrument may be undersized, which could prevent its mating tip from engaging the pedicle screw tulip and rod during tightening. This may lead to surgical delay or the use of alternative methods to complete the final tightening step.
From the FDA notice · Read the official notice ↗
What to do
- Set aside affected units and do not use them in spinal fusion procedures.
- Check UDI-DI M711BTA2020 or M711LS7490 and serial numbers 002, 003, 007, 012, or 014 to identify affected units.
- The notice doesn't say how to get a replacement; contact Innovasis, Inc. about the affected units.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 5
- Illnesses reported
- None reported
- Manufactured in
- 614 E 3900 S, Salt Lake City, UT, United States
- Classification
- Class II
- Recall number
- Z-2859-2026
In the FDA's words
- Description
- Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System 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. LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014 Distribution: US Nationwide distribution in the states of TX, CA. Affected quantity: 5
- 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.