Z-1071-2018 Class II Terminated
FDA device recall Z-1071-2018 was initiated by Zimmer Biomet, Inc. on October 11, 2017 and is designated Class II. Reason for recall: Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate. The recall status is terminated (terminated May 7, 2020). Affected quantity: 14,461.
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- October 11, 2017
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,461
Product Description
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.
Reason for Recall
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Distribution Pattern
US Nationwide Distribution
Code Information
906512, 906513, 906514, 906515