Recall Z-3163-2024— Innovasis, Inc
Class II · Ongoing
Class II FDA medical device recall by Innovasis, Inc, initiated 2024-08-14. It names 3 FDA 510(k) clearances: K201614, K183064, K180078. 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.. Reason: Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device..
- Recalling firm
- Innovasis, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-14
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
3 on FDA's record- K201614 — TxTiHA IBF System, AxTiHA Stand-Alone ALIF System
- K183064 — TxTi IBF System
- K180078 — Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.