# FDA recall Z-0005-2023

> **Wright Medical Technology, Inc.** · Class II · device recall initiated 2022-08-03.

## Product

stryker EVOLVE,  Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.

## Reason for recall

The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0005-2023
- **Recalling firm:** Wright Medical Technology, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-03
- **Report date:** 2022-10-12

- **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-0005-2023

## Citation

> AI Analytics. FDA recall Z-0005-2023. Retrieved 2026-08-13 from https://api.ai-analytics.org/recall/Z-0005-2023. Source: US FDA. Licensed CC0.

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