FDA Medical devices recall ·
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System recall
- Recall number
- Z-2859-2026
- Date
- (initiated May 22, 2026)
- Company / brand
- Innovasis, Inc
614 E 3900 S, Salt Lake City, UT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014
Distribution
US Nationwide distribution in the states of TX, CA.
States: California Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2859-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.