BEUDAMED
    FDA Enforcement Class II 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 · Reported July 22, 2015

    Enforcement

    Recall Number
    Z-2086-2015
    Event ID
    71599
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 22, 2015
    Initiation Date
    June 24, 2015
    Classification Date
    July 16, 2015
    Termination Date
    August 18, 2016
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    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.

    Code Info

    Part Number 399.56 Lot Numbers T106341

    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