# FDA recall Z-2685-2020

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2020-06-24.

## Product

TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.

## Reason for recall

A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.

## Distribution

International distribution in the countries of Brazil, Colombia and United Arab Emirates.

## Key facts

- **Recall number:** Z-2685-2020
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-24
- **Report date:** 2020-07-29
- **Termination date:** 2021-04-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2685-2020

## Citation

> AI Analytics. FDA recall Z-2685-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2685-2020. Source: US FDA. Licensed CC0.

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