BEUDAMED
    FDA Recall Terminated

    Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.

    Recall: Z-1464-2018 · Initiated March 28, 2018

    Recall

    Recall Number
    Z-1464-2018
    Event Number
    79798
    Firm
    Ace Surgical Supply Co., Inc.
    FEI Number
    1287163
    Product Code
    EMO
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    March 28, 2018
    Terminated
    September 11, 2018
    Address
    1034 Pearl St, Brockton, MA, 02301-5411

    Description

    Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.

    Reason

    The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.

    Action

    ACE is contacting the 5 affected customers via certified mail for US customers and via email for non-US Customers. Follow-up notifications will be sent 12 weeks after initial notification. Firm will rework incorrectly packaged product and will use completed reply forms as effectiveness check. For further questions, please call (508) 588-3100.

    Distribution

    US Distribution to the states of : MI, CA, OK, and Internationally to China, Canada,

    Quantity

    6