BEUDAMED
    FDA Enforcement Class II Terminated

    The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.

    Recall: Z-1457-2014 · Reported April 23, 2014

    Enforcement

    Recall Number
    Z-1457-2014
    Event ID
    67560
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 23, 2014
    Initiation Date
    February 11, 2014
    Classification Date
    April 15, 2014
    Termination Date
    September 10, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.

    Reason

    The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22.

    Code Info

    part no. 399.24, lot number T974302

    Distribution

    Worldwide Distribution - USA Nationwide Distribution in the states of: TN, MD, NY, IN, NJ, WA, VA,and the country of Canada.

    Quantity

    20