# FDA recall Z-2163-2018

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2018-05-04.

## Product

smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)

## Reason for recall

One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.

## Distribution

International only:  United Arab Emirates, Spain, Mexico

## Key facts

- **Recall number:** Z-2163-2018
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-04
- **Report date:** 2018-06-20
- **Termination date:** 2019-02-22

- **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-2163-2018

## Citation

> AI Analytics. FDA recall Z-2163-2018. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-2163-2018. Source: US FDA. Licensed CC0.

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