Zimmer Biomet recalls certain TunneLoc Tibial Fixation Devices due to potential inadequate sterilization validation, which may affect surgical safety. Affected models include 906512-906:15.
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Zimmer Biomet is recalling specific models of TunneLoc Tibial Fixation Devices because gamma sterilization testing might not have been sufficient. This could lead to improper sterilization and potential infection risks during surgery.
The gamma sterilization validation testing indicates the sterilization dose might not be adequate. This could mean the devices are not properly sterilized, increasing the risk of infection during surgical procedures.
Surgical teams using the recalled models for ACL or PCL reconstruction procedures are most at risk. Patients undergoing these surgeries with the affected devices may face infection risks.
Check the device model numbers: 906512, 906513, 906514, or 906515. These models were sold for use in anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction surgeries.
Identify the model number on the device: 906512, 906513, 906514, or 906515.
Gamma sterilization validation testing indicates the sterilization dose may not be adequate, potentially leading to improper sterilization.
Models 906512, 906513, 906514, and 906515.
The recall record does not specify a remedy, so contact Zimmer Biomet directly for guidance.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1071-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1071-2018 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.
