Recall Z-2859-2026— Innovasis, Inc
Class II · Ongoing
Class II FDA medical device recall by Innovasis, Inc, initiated 2026-05-22. It names 3 FDA 510(k) clearances: K251073, K250182, K241276. Product: Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System. Reason: 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..
- Recalling firm
- Innovasis, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-05-22
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
3 on FDA's record- K251073 — Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
- K250182 — Innovasis Navigation Instruments
- K241276 — Vector Pedicle Screw System
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.