BEUDAMED
    FDA Recall Terminated

    Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.

    Recall: Z-1341-2013 · Initiated April 12, 2013

    Recall

    Recall Number
    Z-1341-2013
    Event Number
    64943
    Firm
    Coloplast Manufacturing US, LLC
    FEI Number
    2125050
    Product Code
    OTO
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    April 12, 2013
    Posted
    May 20, 2013
    Terminated
    January 21, 2014
    Address
    1601 W River Rd, Minneapolis, MN, 55411-3431

    Description

    Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.

    Reason

    Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging.

    Action

    Coloplast sent a letter to dated April 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter included an attachment with the correct IFU to replace the incorrect IFU. Customers with questions were instructed to call Customer Service at 800-258-3476. For questions regarding this recall call 612-302-4992.

    Distribution

    Nationwide Distribution including AL, CA, CO, DC, IL, IN, KY, MD, MA, MO, NH, OH, RI, and VA.

    Quantity

    111