BEUDAMED
    FDA Enforcement Class II 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 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1464-2018
    Event ID
    79798
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ace Surgical Supply Co., Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 2, 2018
    Initiation Date
    March 28, 2018
    Classification Date
    April 20, 2018
    Termination Date
    September 11, 2018
    Address
    1034 Pearl St, N/A, Brockton, MA, 02301-5411, United States

    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.

    Code Info

    Lot # M050225

    Distribution

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

    Quantity

    6