# FDA recall Z-2091-2020

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2020-04-16.

## Product

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)

## Reason for recall

The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.

## Distribution

Worldwide distribution including the following states: New York, Arkansas, Oklahoma, Michigan, Delaware, Texas, Louisiana, California, Florida, Arizona, Nevada, Ohio, Colorado, Rhode Island, Iowa, Pennsylvania, Massachusetts, North Carolina, Alabama, New Hampshire, Illinois, New Jersey, Virginia, Utah, Maryland, Mississippi, Missouri, Tennessee, Connecticut, and Kansas

## Key facts

- **Recall number:** Z-2091-2020
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-16
- **Report date:** 2020-05-27
- **Termination date:** 2021-11-15

- **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-2091-2020

## Citation

> AI Analytics. FDA recall Z-2091-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2091-2020. Source: US FDA. Licensed CC0.

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