BEUDAMED
    FDA Enforcement Class II Terminated

    Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site

    Recall: Z-1783-2013 · Reported July 31, 2013

    Enforcement

    Recall Number
    Z-1783-2013
    Event ID
    65679
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pemco Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2013
    Initiation Date
    July 10, 2013
    Classification Date
    July 22, 2013
    Termination Date
    February 11, 2014
    Address
    5663 Brecksville Rd, N/A, Independence, OH, 44131-1510, United States

    Description

    Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site

    Reason

    The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion.

    Code Info

    M/N 4100-IMR-6: S/N's: 4829-4839, 4845-4851, 4857-4871, 4874-4884, 4894-4908 & 4916-4923; M/N 4100-IMR-41: S/N's: 4840-4844, 4852-4856, 4888-4893, 4913-4915 & 4926-4927.

    Distribution

    Worldwide Distribution - USA including AL, CA, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, OK, PA, TN, TX, UT, VA & WA. Internationally to Czech Republic, Italy, Japan, Korea & Singapore.

    Quantity

    87 units