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Howmedica Osteonics Corp. recalls Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07
Recalled May 27, 2020 · FDA recall Z-2087-2020 · Howmedica Osteonics
Hazard
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. · FDA Class II
Units
4895
Sold at
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
Description
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.
Product
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)
Manufacturer(s)
Howmedica Osteonics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →