BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.

    Recall: Z-1726-2013 · Reported July 24, 2013

    Enforcement

    Recall Number
    Z-1726-2013
    Event ID
    65670
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2013
    Initiation Date
    June 12, 2013
    Classification Date
    July 12, 2013
    Termination Date
    September 21, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.

    Reason

    The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot in the barrel of the BC distractor was rotated such that it was not possible to attach the B-type and C-type foot plates.

    Code Info

    Part # 04.315.067 with lot #s 6184270 and/or 22612-04.

    Distribution

    Nationwide Distribution including PA, CT, DE, and NY.

    Quantity

    10