BEUDAMED
    FDA Recall 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 · Initiated April 4, 2013

    Recall

    Recall Number
    Z-1276-2013
    Event Number
    64988
    Firm
    Medshape Solutions, INC.
    FEI Number
    3007593722
    Product Code
    MBI
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    April 4, 2013
    Posted
    May 8, 2013
    Terminated
    August 7, 2013
    Address
    1575 Northside Dr Nw, Ste 440, Atlanta, GA, 30318-4211

    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.

    Action

    Medshape sent an "URGENT: MEDICAL DEVICE RECALL" letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

    Distribution

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

    Quantity

    26