BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.

    Recall: Z-0394-2014 · Reported December 4, 2013

    Enforcement

    Recall Number
    Z-0394-2014
    Event ID
    66580
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2013
    Initiation Date
    October 3, 2013
    Classification Date
    November 26, 2013
    Termination Date
    December 18, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.

    Reason

    During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.

    Code Info

    part 219.951 with multiple lot#: 2335941 2339634 2397429 2405812 2440475 2442736 2496414 5661855 5663841

    Distribution

    Nationwide Distribution

    Quantity

    3087