# FDA recall Z-0097-2018

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2017-10-24.

## Product

smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL

## Reason for recall

A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.

## Distribution

US Distribution - TN, IL, CT, MO, CA., and Internationally to Italy and  Germany

## Key facts

- **Recall number:** Z-0097-2018
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2017-10-24
- **Report date:** 2017-11-22

- **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-0097-2018

## Citation

> AI Analytics. FDA recall Z-0097-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0097-2018. Source: US FDA. Licensed CC0.

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