# FDA recall Z-1507-2020

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2019-12-19.

## Product

LEGION PS High Flex XLPE size 5-6 9mm Articular Insert

## Reason for recall

LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part

## Distribution

USA:  TN, NC, CA,OR, NM, TX, PA, MI, LA, DA, IL.  Int'l:  IT (Italy), NL (Netherlands), RO (Romania), PR (Puerto Rico).

## Key facts

- **Recall number:** Z-1507-2020
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-19
- **Report date:** 2020-03-25
- **Termination date:** 2024-09-04

- **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-1507-2020

## Citation

> AI Analytics. FDA recall Z-1507-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-1507-2020. Source: US FDA. Licensed CC0.

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