BEUDAMED
    FDA Recall Terminated

    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)

    Recall: Z-2087-2020 · Initiated April 16, 2020

    Recall

    Recall Number
    Z-2087-2020
    Event Number
    85583
    Firm
    Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    April 16, 2020
    Posted
    May 7, 2020
    Terminated
    November 15, 2021
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006

    Description

    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)

    Reason

    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.

    Action

    Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm 68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.

    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

    Quantity

    4895