BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.

    Recall: Z-1952-2013 · Reported August 21, 2013

    Enforcement

    Recall Number
    Z-1952-2013
    Event ID
    65560
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2013
    Initiation Date
    June 11, 2013
    Classification Date
    August 12, 2013
    Termination Date
    August 31, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417, United States

    Description

    Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.

    Reason

    Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion on the device exists. The potential for harm exists if there is an introduction of foreign material at the operative site originating from the presence of corrosion and/or the retained undefined material that could not be adequately cleaned.

    Code Info

    All lots with part number 359.106, 359.107, 359.108, 359.109, 359.110, 359.111, 359.112, 359.113, 359.114, 359.115

    Distribution

    Nationwide Distribution.

    Quantity

    13,050