# FDA recall Z-2702-2018

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2017-10-24.

## Product

Radio Capitellum, Recon Head, Size #4.  Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

## Reason for recall

Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.

## Distribution

Distribution US Nationwide.

## Key facts

- **Recall number:** Z-2702-2018
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-24
- **Report date:** 2018-08-15
- **Termination date:** 2023-05-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2702-2018

## Citation

> AI Analytics. FDA recall Z-2702-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2702-2018. Source: US FDA. Licensed CC0.

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