TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i — Class II medical device recall Z-3163-2024
Ongoing recall by Innovasis, Inc, reported 2024-09-25, distributed nationwide. Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
| Recall number | Z-3163-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Innovasis, Inc, Salt Lake City, UT, United States |
| Recall initiated | 2024-08-14 |
| Classified | 2024-09-17 |
| Reported by FDA | 2024-09-25 |
| Distributed | Nationwide (US) |
| Quantity | 568 devices |
| Serial numbers | 001-012, 013-024, 013-025, 013-026, 013-027, 013-028 |
| Model numbers | BTA-151 |
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 for recall
Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3163-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.