# FDA recall Z-0366-2022

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2021-11-01.

## Product

smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202

## Reason for recall

Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU  81110294 EVOS Large Fragment Plating System.

## Distribution

US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.

## Key facts

- **Recall number:** Z-0366-2022
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-11-01
- **Report date:** 2021-12-22

- **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-0366-2022

## Citation

> AI Analytics. FDA recall Z-0366-2022. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0366-2022. Source: US FDA. Licensed CC0.

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