Innovasis, Inc Recalls

2 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (2)

May 22, 2026
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
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.
Class II
August 14, 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
Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
Class II

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