Class II — TriMed Inc.
| Recalling firm | TRIMED, INC. |
|---|---|
| Registered facility | TRIMED, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | RipCord Syndesmosis Button, REF: STA001K |
| Quantity | 76 |
| Distribution | US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS |
| Initiated | 2022-12-22 |
| Classified | 2023-02-07 |
| Recall number | Z-1101-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — TriMed Inc. (Z-1101-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91478/
Alerts for TRIMED, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.