FDA-Device2018-03-21Class II
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.
Zimmer Biomet, Inc.
Hazard
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Sold states
US Nationwide Distribution
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1072-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief