BEUDAMED
    FDA Enforcement Class II Terminated

    ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons or soft tissue grafts to bone.

    Recall: Z-1276-2013 · Reported May 15, 2013

    Enforcement

    Recall Number
    Z-1276-2013
    Event ID
    64988
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medshape Solutions, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 15, 2013
    Initiation Date
    April 4, 2013
    Classification Date
    May 8, 2013
    Termination Date
    August 7, 2013
    Address
    1575 Northside Dr Nw Ste 440, N/A, Atlanta, GA, 30318-4211, United States

    Description

    ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons or soft tissue grafts to bone.

    Reason

    Expiration date on the patient label and date on the product carton were not the same.

    Code Info

    Lot No. 113011-002

    Distribution

    Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.

    Quantity

    26