Device recall
Z-3163-2024: TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF…
FDA device recall · Class II · Innovasis, Inc
Key facts
| Recall number (Z-number) | Z-3163-2024 |
|---|---|
| Recall event | 95185 |
| 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… |
| Product code | MAX |
| Recalling firm | Innovasis, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K180078, K183064, K201614 |
| FEI number | 3004719693 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database