BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0905-2013 · Initiated January 11, 2013

    Recall

    Recall Number
    Z-0905-2013
    Event Number
    64195
    Firm
    Synthes USA HQ, Inc.
    FEI Number
    3005180112
    Product Code
    DZL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 11, 2013
    Posted
    March 1, 2013
    Terminated
    August 31, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    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.

    Action

    The firm, Synthes (USA) sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated January 11, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firmat 610-719-5450 for questions regarding this notice.

    Distribution

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

    Quantity

    18