Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17)
Reported: May 27, 2020 Initiated: April 16, 2020 #Z-2096-2020
Product Description
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(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.
Details
- Recalling Firm
- Howmedica Osteonics Corp.
- Units Affected
- 4895
- 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
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17). Recalled by Howmedica Osteonics Corp.. Units affected: 4895.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 27, 2020. Severity: Moderate. Recall number: Z-2096-2020.
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