# FDA recall Z-1951-2021

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2021-05-19.

## Product

LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile.  Knee prosthesis component.

## Reason for recall

The device components experienced a manufacturing process error that resulted in surface damage from product handling.

## Distribution

US Nationwide distribution in the states of FL, NE, NY, and TX.  There was no foreign/government/military distribution.

## Key facts

- **Recall number:** Z-1951-2021
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-19
- **Report date:** 2021-06-30
- **Termination date:** 2023-04-14

- **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-1951-2021

## Citation

> AI Analytics. FDA recall Z-1951-2021. Retrieved 2026-08-22 from https://api.ai-analytics.org/recall/Z-1951-2021. Source: US FDA. Licensed CC0.

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