Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported September 25, 2024
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 fu
Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Innovasis, Inc recalled TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF Syst… - a moderate-severity action.
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF Syst… was recalled by Innovasis, Inc in September 25, 2024. Reason: Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.. Check the official notice for the remedy. Verify recall #Z-3163-2024 with the FDA Devices before acting.
The recall
Innovasis, Inc issued this moderate-severity FDA Devices recall-Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device..
- Moderate
- severity level
- 568 units
- affected scope
- Class II
- classification
- September 25, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3163-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3163-2024) was formally reported on September 25, 2024, with the manufacturer initiating the action on August 14, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Innovasis, Inc is listed as the recalling firm, operating out of Salt Lake City, UT. Federal records list the affected scope as 568 devices.
The documented reason for this recall is: Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device. Distribution data in the federal record shows the product reached: U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
568 devices
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-3163-2024 |
| Date reported | September 25, 2024 |
| Date initiated | August 14, 2024 |
| Recalling firm | Innovasis, Inc |
| Firm location | Salt Lake City, UT |
| Affected scope | 568 devices |
| Distribution | U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-3163-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Innovasis, Inc. Units affected: 568 devices.
Why was this product recalled? ▼
Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 25, 2024. Severity: Moderate. Recall number: Z-3163-2024.
Where was the recalled product distributed? ▼
Distribution: U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3163-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 25, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.