Recall Z-1071-2018 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Zimmer Biomet, Inc.
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.
| Date | Oct 11, 2017 |
| Status | Terminated |
| Reason | Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate. |
| Root cause | Vendor change control |
| Action | 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 |
| Quantity | 14,461 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103145 | HAMMERLOC TM TIBIAL FIXATION DEVICE Biomet Sports Medicine, Feb 9, 2011 |