PlainRecalls
FDA Devices Moderate Class II Ongoing

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 fu

Reported: September 25, 2024 Initiated: August 14, 2024 #Z-3163-2024

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Innovasis, Inc
Units Affected
568 devices
Distribution
U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI.
Location
Salt Lake City, UT

Frequently Asked Questions

What product 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.. Recalled by Innovasis, Inc. Units affected: 568 devices.
Why was this product recalled? ▼
Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 25, 2024. Severity: Moderate. Recall number: Z-3163-2024.

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