BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1457-2014 · Initiated February 11, 2014

    Recall

    Recall Number
    Z-1457-2014
    Event Number
    67560
    Firm
    Synthes, Inc.
    FEI Number
    3005180112
    Product Code
    GAD
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    February 11, 2014
    Posted
    April 15, 2014
    Terminated
    September 10, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    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.

    Action

    Synthes sent an Urgent Notice: Medical Device Recall letter dated February 11, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to Complete the attached Verification Section form. For questions call 610-719-5450.

    Distribution

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

    Quantity

    20