Innovasis TxHA PEEK IBF System Recall: Interfacing Issues with Implant Trial
Innovasis recalls specific spinal fusion implants due to interfacing issues between the implant trial and inserter, which could lead to improper device function during surgery.
Recall notice
Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
Contact the company
What happened, in plain English
Innovasis is recalling certain spinal fusion implants (TxHA PEEK IBF System) because they may not interface correctly with the inserter during surgery. This could lead to improper fusion or complications if used without addressing the issue. Read more at govinfonow.com/recall/54234-innovasis-txha-peek-ibf-system-recall-interfacing-issues-with-implant.
Source Summary by GovInfoNow · govinfonow.com/recall/54234-innovasis-txha-peek-ibf-system-recall-interfacing-issues-with-implant · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3163-2024
Cite this page
“Innovasis TxHA PEEK IBF System Recall: Interfacing Issues with Implant Trial.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54234-innovasis-txha-peek-ibf-system-recall-interfacing-issues-with-implant. Based on FDA recall #Z-3163-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3163-2024%22&limit=1).
Why it’s dangerous
The recall is due to potential interfacing issues between the implant trial and the inserter device during spinal fusion surgery. This could result in improper device function, which might lead to complications like failed fusion or unintended movement of the spinal segment.
Who’s affected
Physicians trained in orthopedic surgery who use these spinal fusion implants for intervertebral body fusion procedures are most at risk. The affected devices are specific implant trials sold to hospitals and surgical sites.
How to tell if you have this one
Check for the specific implant trial models listed in the recall: LS-397-0705 to LS-433-1112 with serial numbers 001-027. These devices have unique UDI-DI codes and dimensions as described in the recall notice.
- Brand
Innovasis- Category
Medical device
What to do — step by step
Check Device Details
Review the UDI-DI code and serial numbers on your implant trial to confirm if it matches the recalled models listed in the notice.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
FDA distribution: “U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Colorado, Florida, Idaho, Michigan, South Dakota, Texas, Wisconsin.
Recall timeline
FDA published this recall 42 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3163-2024 (August 14, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3163-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.