# FDA recall Z-1101-2023

> **TriMed Inc.** · Class II · device recall initiated 2022-12-22.

## 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.

## Distribution

US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS

## Key facts

- **Recall number:** Z-1101-2023
- **Recalling firm:** TriMed Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-22
- **Report date:** 2023-02-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Clarita, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1101-2023

## Citation

> AI Analytics. FDA recall Z-1101-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1101-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*