Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TunneLoc Tibial Fixation Device Product Usage: To provide fixation of Recalled by Zimmer Biomet, Inc. Due to Gamma sterilization validation testing indicates the sterilization dose...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer Biomet, Inc. directly.
Affected Products
TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
Quantity: 14,461
Why Was This Recalled?
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zimmer Biomet, Inc.
Zimmer Biomet, Inc. has 875 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report