BEUDAMED
    FDA Recall 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 · Initiated July 10, 2013

    Recall

    Recall Number
    Z-1783-2013
    Event Number
    65679
    Firm
    Pemco Inc
    FEI Number
    1519227
    Product Code
    GAD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 10, 2013
    Posted
    July 22, 2013
    Terminated
    February 11, 2014
    Address
    5663 Brecksville Rd, Independence, OH, 44131-1510

    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.

    Action

    Rultract Skyhook sent a Recall Notification letter dated July 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify the device and return preferably just the gearbox portion of the device to: Pemco, Inc. Attn: Cover Plate Replacement 5663 Brecksville Road Independence, OH 44131 For customers who are unable to send the gearbox for recall service, Pemco would replace the Cover Plate free of charge. Customers with questions were instructed to call 216-524-2990, ext 103. For questions regarding this recall call 216-524-2990.

    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