Zimmer Biomet recalls AIM Tibial Nails intramedullary fixation rods with item numbers 800508255-800513420 due to high surgical revision rates. Consumers should check their product details and contact the company for guidance.
The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
Zimmer Biomet is recalling AIM Tibial Nails intramedullary fixation rods because clinical tests showed these implants had a higher revision rate than acceptable. This means the rods might need to be removed and replaced more often than expected, which could lead to complications for patients.
These rods were found to have a higher revision rate than the acceptable standard in clinical testing. Revision rate refers to how often the implants need to be removed and replaced due to failure. This could lead to additional surgeries and complications for patients.
Patients who received these specific AIM Tibial Nails rods during surgery are most at risk. The recall applies to all units with the listed item numbers.
Check the item numbers on the rod packaging: 800508255 through 800513420. These are the specific models of AIM Tibial Nails that were recalled. The product is a sterile intramedullary fixation rod used in bone fractures.
Identify the item number on your rod packaging to confirm if it's in the recalled range (800508255-800513420).
The recall is due to clinical tests showing a higher revision rate than the acceptable standard for these implants.
If you have the recalled item numbers, contact Zimmer Biomet directly for guidance on next steps.
Look for the item numbers on the packaging: 800508255 through 800513420.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1196-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1196-2018 from Zimmer Biomet. 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.
