# FDA recall Z-0118-2021

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2020-09-21.

## Product

Genesis (GII) - Product Usage: 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

The anterior locking detail does not meet its design specifications.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of CA, NH, NY, GA, MI, TX, IL, OK, LA, OR, FL, AZ, NJ, MO and the countries of AE. BE, BR, CO, DE, ES, FR, GB, HU, IT, PL, PT, TR.

## Key facts

- **Recall number:** Z-0118-2021
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2020-09-21
- **Report date:** 2020-10-28

- **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-0118-2021

## Citation

> AI Analytics. FDA recall Z-0118-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0118-2021. Source: US FDA. Licensed CC0.

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