Zimmer Biomet recalls TunneLoc Tibial Fixation Devices in ACL kits due to potential inadequate sterilization. This may affect surgical implants used in ACL/PCL reconstruction procedures.
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Zimmer Biomet is recalling certain TunneLoc Tibial Fixation Devices that come with ACL kits. The recall is because gamma sterilization testing might not have reached the required dose, which could lead to contamination during surgery.
The gamma sterilization process might not have delivered enough radiation to properly kill all bacteria. This could mean the device isn't sterile when used in surgery, potentially causing infections or complications for patients.
Surgical patients undergoing ACL or PCL reconstruction procedures who received the specific kits (PNs 906532-906535) from Zimmer Biomet. Surgeons and medical facilities using these kits are most at risk.
Check if your ACL kit has product numbers 906532, 906533, 906534, or 906535. These kits are distributed non-sterile and come with instructions for use.
Look for the product numbers 906532, 906533, 906534, or 906535 on the kit box.
The recall indicates potential inadequate sterilization, but the device is not safe for surgical use without proper validation.
The recall does not specify a remedy, so contact Zimmer Biomet directly for guidance.
Check the product numbers on the kit box: 906532, 906533, 906534, or 906535.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1072-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1072-2018 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.
