FDA Device recall Z-1071-2018
TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate…
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate… by Zimmer Biomet, citing gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1071-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-11 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
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
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Identifiers
| code_info | 906512, 906513, 906514, 906515 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1071-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.