Innovasis, Inc recalls TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion…

Recall date

August 14, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3163-2024

FDA classification

Class II

Brand / firm

Innovasis, Inc

Sold / distributed

U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI.

Why it was recalled

Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery. ii. TxTiHA The Innovasis TxTiHA IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.