BEUDAMED
    FDA Enforcement Class II Terminated

    Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes

    Recall: Z-2155-2015 · Reported July 29, 2015

    Enforcement

    Recall Number
    Z-2155-2015
    Event ID
    71509
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cochlear Americas Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 29, 2015
    Initiation Date
    June 5, 2015
    Classification Date
    July 20, 2015
    Termination Date
    August 5, 2015
    Address
    13059 E Peakview Ave, N/A, Centennial, CO, 80111-6511, United States

    Description

    Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes

    Reason

    Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.

    Code Info

    Lot numbers: COH471122 Expiration 5/6/15 and Lot COH471123 Expiration 4/24/15

    Distribution

    US Nationwide Distribution to CO, OH, OR, MI, and CA.

    Quantity

    26