BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1341-2013 · Reported May 29, 2013

    Enforcement

    Recall Number
    Z-1341-2013
    Event ID
    64943
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Coloplast Manufacturing US, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2013
    Initiation Date
    April 12, 2013
    Classification Date
    May 20, 2013
    Termination Date
    January 21, 2014
    Address
    1601 W River Rd, N/A, Minneapolis, MN, 55411-3431, United States

    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.

    Code Info

    3483171

    Distribution

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

    Quantity

    111