Z-2091-2020 Class II Terminated
FDA device recall Z-2091-2020 was initiated by Howmedica Osteonics Corp. on April 16, 2020 and is designated Class II. 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. The recall status is terminated (terminated November 15, 2021). Affected quantity: 4895.
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- April 16, 2020
- Termination Date
- November 15, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4895
Product Description
Reason for Recall
Distribution Pattern
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