BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.

    Recall: Z-0942-2013 · Reported March 20, 2013

    Enforcement

    Recall Number
    Z-0942-2013
    Event ID
    64287
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 20, 2013
    Initiation Date
    January 11, 2013
    Classification Date
    March 11, 2013
    Termination Date
    August 31, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.

    Reason

    There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized.

    Code Info

    All Lots

    Distribution

    Worldwide Distribution -- USA, including the states of CA, LA, MA, NY, and PA, and the countries of Canada and Switzerland.

    Quantity

    596