FDA Device recall Z-1734-2018
Gentle Threads, Interference Screw
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Gentle Threads, Interference Screw by Zimmer Biomet, citing specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1734-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-28 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.
Reason
Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Identifiers
| code_info | lot 207910 |
|---|
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-1734-2018%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.