# FDA recall Z-1902-2018

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2018-04-09.

## Product

smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014    The GENESIS II 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.

## Reason for recall

A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. The left valgus bushing was incorrectly laser marked as right and vice versa.

## Distribution

US Distribution to the states of : NC, IN, CO MI, PA, NY, MA, CA, GA

## Key facts

- **Recall number:** Z-1902-2018
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-09
- **Report date:** 2018-05-30
- **Termination date:** 2019-02-22

- **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-1902-2018

## Citation

> AI Analytics. FDA recall Z-1902-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-1902-2018. Source: US FDA. Licensed CC0.

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