# FDA recall Z-0772-2021

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2020-11-02.

## Product

Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;

## Reason for recall

Manufacturing packaging error.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, IA, KY, MI, NC, NJ, OH, PA, TN, TX, WA and the countries of AU, CA & GB.

## Key facts

- **Recall number:** Z-0772-2021
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-02
- **Report date:** 2021-01-13
- **Termination date:** 2023-01-06

- **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-0772-2021

## Citation

> AI Analytics. FDA recall Z-0772-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0772-2021. Source: US FDA. Licensed CC0.

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