BEUDAMED
    FDA Recall Terminated

    Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

    Recall: Z-0007-2018 · Initiated July 21, 2017

    Recall

    Recall Number
    Z-0007-2018
    Event Number
    77788
    Firm
    Implant Direct Sybron Manufacturing, LLC
    FEI Number
    3001617766
    Product Code
    NHA
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 21, 2017
    Terminated
    April 1, 2021
    Address
    3050 E Hillcrest Dr, Westlake Village, CA, 91362-3171

    Description

    Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

    Reason

    The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.

    Action

    Recall notification letters were sent to consignees, via mail on 07/21/2107. Instructions included to review current inventory and remove affected product, to complete and return the Acknowledgement and Recall Return form, and to notify customers who received product if it was further distributed.

    Distribution

    Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.

    Quantity

    50 units