BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.

    Recall: Z-0429-2014 · Reported December 11, 2013

    Enforcement

    Recall Number
    Z-0429-2014
    Event ID
    66530
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 11, 2013
    Initiation Date
    August 1, 2013
    Classification Date
    November 29, 2013
    Termination Date
    April 16, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.

    Reason

    The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.

    Code Info

    Part J5957AC (old), and Part J5957F (new)

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada and Mexico.

    Quantity

    374