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Zimmer Biomet, Inc. recalls TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within
Recalled March 21, 2018 · FDA recall Z-1072-2018 · Zimmer Biomet
Hazard
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate. · FDA Class II
Sold at
US Nationwide Distribution
Description
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Product
TunneLoc Tibial Fixation Device (Within an ACL Kit) 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.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →