BEUDAMED
    FDA Recall Terminated

    9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants

    Recall: Z-1150-2017 · Initiated January 3, 2017

    Recall

    Recall Number
    Z-1150-2017
    Event Number
    76146
    Firm
    Stryker Leibinger GmbH & Co. KG Botzinger Strasse 41 Freiburg Germany
    FEI Number
    3002821504
    Product Code
    GCY
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    January 3, 2017
    Posted
    February 8, 2017
    Terminated
    July 27, 2017

    Description

    9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants

    Reason

    An incorrect sterility status on the label, non-sterile products labeled as sterile

    Action

    Stryker sent an " URGENT MEDICAL DEVICE RECALL" notifications dated January 3, 2017, to the affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, instructions for returning affected product, and instructions for responding to the formal recall notification. Please report any adverse events or product quality problems to Stryker CMF Customer Service: 1 (800) 962-6558.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.

    Quantity

    619