Innovasis, Inc: Device Recall
Recall #Z-3163-2024 · 08/14/2024
Recall Details
- Recall Number
- Z-3163-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Innovasis, Inc
- Status
- Ongoing
- Date Initiated
- 08/14/2024
- Location
- Salt Lake City, UT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 568 devices
Reason for Recall
Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
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.
Distribution Pattern
U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI.