Salt Lake City, UT, United States
Innovasis, Inc recalls
4 recalls recorded since 2018, most recently on 22 May 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)2
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 22 May 2026
- 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.
- Distribution
- US Nationwide distribution in the states of TX, CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2859-2026
- Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Ongoing Class II Medical devices
- Recall started
- 14 August 2024
- Reason
- Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
- Distribution
- U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3163-2024
- TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to r
Terminated Class II Medical devices
- Recall started
- 7 April 2020
- Terminated
- 26 January 2022
- Reason
- Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. The caddy location labeled as "Fixed" should be labeled as "Variable" and the caddy location labeled as "Variable" should be labeled as "Fixed. If user installs a fixed rescue screw instead of variable, the screw head may not be flush, it could back out, which could interfere with the cover screw.
- Distribution
- US Nationwide distribution including in the states of CA, AL, LA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2062-2020
- Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intended for use in anterior cervical fixation.
Terminated Class II Medical devices
- Recall started
- 8 January 2018
- Terminated
- 27 February 2018
- Reason
- Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.
- Distribution
- United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0644-2018
- Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the fo
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.