FDA Closes Recall of Innovasis Vector Pedicle Screw System Tools
The FDA has closed its recall action for five anti-torque spinal surgery instruments manufactured by Innovasis, Inc.
2 reports on this incident · first at Aug 19, 2026, 8:42 p.m. ET
Earlier reports
Aug 19, 2026, 8:42 p.m. ETFirst report
FDA Classifies Ongoing Recall of Innovasis Spinal Surgery Tools
On August 12, 2026, the Food and Drug Administration issued a Class II classification for an ongoing recall initiated on May 22, 2026, by Salt Lake City, Utah-based Innovasis, Inc. The action involves five units of the Anti-Torque, Vector, Part: LS-749, which functions as part of the Vector Pedicle Screw System.
According to FDA enforcement report Z-2859-2026, the affected devices are identified by code LS-749, UDI-DI codes M711BTA2020 and M711LS7490, and serial numbers 002, 003, 007, 012, and 014. The pedicle screw system is intended for immobilization or stabilization of spinal segments as an adjunct to thoracic, lumbar, or sacral spine fusion. The agency noted that the anti-torque instrument may have an undersized condition, which could prevent the mating tip from engaging with the pedicle screw tulip and rod during tightening. This may result in surgical delays or necessitate intervention and alternative methods to perform the final tightening step.
Distribution was nationwide across Texas and California. The FDA defines a Class II classification as a situation where use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA database records show no other enforcement actions on file for this firm.
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- Version 120 Aug 2026, 00:42current
First published.
- Version 120 Aug 2026, 00:56current
First published.
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