BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.

    Recall: Z-0905-2013 · Reported March 13, 2013

    Enforcement

    Recall Number
    Z-0905-2013
    Event ID
    64195
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 13, 2013
    Initiation Date
    January 11, 2013
    Classification Date
    March 1, 2013
    Termination Date
    August 31, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.

    Reason

    It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.

    Code Info

    Part number 487.967 - Lot numbers 7883454, 3808876, 7824423, 3800758, 3817116, 3794466

    Distribution

    Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.

    Quantity

    18