Zimmer Biomet recalls AIM Tibial Nails intramedullary fixation rods due to high surgical revision rates. These non-sterile rods require sterilization before use and are affected by specific item numbers.
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 certain AIM Tibial Nails intramedullary fixation rods because they failed clinical analysis showing a high revision rate. This means the rods might not stay in place properly after surgery, potentially requiring additional procedures.
The rods failed clinical testing where the surgical revision rate exceeded safety standards. This means the rods may not stay in place properly after surgery, requiring additional procedures to fix the problem.
Patients who have received these specific AIM Tibial Nails rods during surgery are affected. Surgeons and medical facilities using the recalled item numbers are at risk of needing additional procedures.
Check the item numbers listed in the recall: 810508255, 810508270, and other specific model numbers. These rods are non-sterile and must be sterilized before use.
Look for the specific item numbers listed in the recall: 810508255, 810508270, and other model numbers.
The AIM Tibial Nails failed clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol.
If you have the recalled item numbers, you should check with your surgeon or medical facility about next steps, as the product requires sterilization before use.
This product is non-sterile and must be sterilized prior to use. The recall indicates a higher risk of needing additional procedures after surgery.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1197-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1197-2018 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.
