FDA Device recall Z-1101-2023
RipCord Syndesmosis Button, REF: STA001K
- FDA Device
- Class II
- ongoing
- Published 2023-02-15
On 2023-02-15 the FDA classified a Class II recall of RipCord Syndesmosis Button, REF: STA001K by Trimed, citing overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1101-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-22 |
| Published | 2023-02-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Trimed |
| Distribution | US |
Product
RipCord Syndesmosis Button, REF: STA001K
Reason
Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.
Identifiers
| code_info | UDI-DI: 00842188123849, Lot: 85305-01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1101-2023%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.