# FDA recall Z-0092-2018

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2017-09-14.

## Product

smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R    Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use 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 Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.

## Distribution

US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, Thailand

## Key facts

- **Recall number:** Z-0092-2018
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-14
- **Report date:** 2017-11-22
- **Termination date:** 2020-08-21

- **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-0092-2018

## Citation

> AI Analytics. FDA recall Z-0092-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0092-2018. Source: US FDA. Licensed CC0.

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