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.
Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
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.
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.
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.
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.
Review the UDI-DI code and serial numbers on your implant trial to confirm if it matches the recalled models listed in the notice.
The recall is due to interfacing issues between the implant trial and inserter during spinal fusion surgery, which could lead to improper device function.
The affected models include implant trials with part numbers LS-397-0705 to LS-433-1112, each with specific serial numbers and dimensions.
The recall does not specify a stop-use instruction; affected devices should be checked against the listed models before use.
We’ve drafted a message you can send Innovasis to request your refund or repair — edit it as you like.
Subject: Recall Z-3163-2024 — Innovasis Innovasis Hello, I own a Innovasis that is covered by recall Z-3163-2024 from Innovasis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
