Device 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.
Z-1072-2018
Product summary
- Event
- Event 79263
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1072-2018
Official wording
Reason: Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Code information: The kits that include the TunneLoc products, ACL in a box, PNs 906532, 906533, 906534, and 906535 are packed in a box alongside the Instructions for use and is distributed non-sterile .
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.