# FDA recall Z-1105-2018

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2018-02-01.

## Product

smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE     The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Revision Knee Components are for single use only and are intended for implantation with bone cement.

## Reason for recall

The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5.

## Distribution

Worldwide Distribution - US Distribution to the states of: NY, IL, NJ, TX, CO,  and to the countries of : Belgium, Great Britain, Australia, Germany, Netherlands, Norway.

## Key facts

- **Recall number:** Z-1105-2018
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-01
- **Report date:** 2018-03-28
- **Termination date:** 2018-10-22

- **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-1105-2018

## Citation

> AI Analytics. FDA recall Z-1105-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1105-2018. Source: US FDA. Licensed CC0.

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