FDAFDA · Food and drugs·Recall number Z-2859-2026
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Published August 12, 2026 · Recall initiated: May 22, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Innovasis, Inc
- Distributor
- US Nationwide distribution in the states of TX, CA.
- Lot
- LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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