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Innovasis, Inc recalls TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fu
Recalled September 25, 2024 · FDA recall Z-3163-2024 · Innovasis
Hazard
Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device. · FDA Class II
Units
568 devices
Sold at
U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI.
Description
Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
Product
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.
Manufacturer(s)
Innovasis, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →