RipCord Syndesmosis Button — Class II medical device recall Z-1101-2023
Ongoing recall by TriMed Inc., reported 2023-02-15, distributed nationwide. Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunne
| Recall number | Z-1101-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TriMed Inc., Santa Clarita, CA, United States |
| Recall initiated | 2022-12-22 |
| Classified | 2023-02-07 |
| Reported by FDA | 2023-02-15 |
| Distributed | Nationwide (US) |
| Quantity | 76 |
| Reason classes | potency, device malfunction |
| UPC / GTIN / UDI-DI | 00842188123849 |
| Lot numbers | 85305-01 |
| Model numbers | STA001K |
Product
RipCord Syndesmosis Button, REF: STA001K
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1101-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.