Recall Z-1072-2018
Zimmer Biomet, Inc. · initiated October 11, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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 .
Reason for recall
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
FDA-determined cause: Vendor change control
Action taken
Zimmer Biomet sent an URGENT MEDICAL DEVICE RECALL letter dated October 16, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review inventory and quarantine affected product, which will be returned to Biomet through a sales representative. Questions or concerns can be directed to 574-371-3071
Details
- Recall number
- Z-1072-2018
- Initiated
- October 11, 2017
- Terminated
- May 7, 2020
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Distribution
- US Nationwide Distribution
- Recalling firm
- Zimmer Biomet, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1071-2018 Class II | TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts…Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate. | 10/11/2017Terminated |