Summary
The FDA issued a Class II for Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System by Innovasis, Inc. Reason: Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have an.
Details
Source
Device Recall
External ID
Z-2859-2026
Action Date
2026-08-12
Status
Ongoing
Category
device
Product Description
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Lot/Code Info: LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014
Quantity Affected: 5
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
US Nationwide distribution in the states of TX, CA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-22
Company
Salt Lake City, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 400 device-related FDA actions this month.
Innovasis, Inc has 10 FDA actions in our database, including 2 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Innovasis, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Innovasis, Inc have FDA actions?
Innovasis, Inc has 10 FDA actions in our database, including 2 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2859-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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