BEUDAMED
    FDA Recall Terminated

    16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument.

    Recall: Z-2086-2015 · Initiated June 24, 2015

    Recall

    Recall Number
    Z-2086-2015
    Event Number
    71599
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    FZO
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    June 24, 2015
    Posted
    July 16, 2015
    Terminated
    August 18, 2016
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument.

    Reason

    It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.

    Action

    DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated June 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Recipients were asked to check inventory and return affected devices along with the completed response form. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.

    Distribution

    US Distribution to the states of : NJ, VA, OH, IN, MI, FL, WI, CA, TN, MD, NC, WA, UT, ID, MO, NV and KS.

    Quantity

    100