# FDA recall Z-3163-2024

> **Innovasis, Inc** · Class II · device recall initiated 2024-08-14.

## 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.

## Distribution

U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI.

## Key facts

- **Recall number:** Z-3163-2024
- **Recalling firm:** Innovasis, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-14
- **Report date:** 2024-09-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salt Lake City, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3163-2024

## Citation

> AI Analytics. FDA recall Z-3163-2024. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-3163-2024. Source: US FDA. Licensed CC0.

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