# FDA recall Z-1905-2018

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2018-03-30.

## Product

smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

## Reason for recall

The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.

## Distribution

US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore

## Key facts

- **Recall number:** Z-1905-2018
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-30
- **Report date:** 2018-05-30
- **Termination date:** 2019-08-21

- **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-1905-2018

## Citation

> AI Analytics. FDA recall Z-1905-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1905-2018. Source: US FDA. Licensed CC0.

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