Z-2859-2026 Class II Ongoing
FDA device recall Z-2859-2026 was initiated by Innovasis, Inc on May 22, 2026 and is designated Class II. Reason for recall: 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 whi… The recall status is ongoing. Affected quantity: 5.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2026
- Initiation Date
- May 22, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
Product Description
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of TX, CA.
Code Information
LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014