Anti-Torque recall (Innovasis, Inc)
Medical deviceClass IIOngoing
Summary: Innovasis, Inc is recalling Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System. Reason: 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 is being recalled
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of TX, CA. (states named: California, Texas)
How to tell if yours is affected
LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2859-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 22, 2026 |
| Reported | August 12, 2026 |
| Company | Innovasis, Inc |
| Company location | Salt Lake City, UT, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 5 |
More recalls from Innovasis, Inc · all medical device recalls · recalls from May 2026