BEUDAMED
    FDA Enforcement Class II Ongoing

    Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

    Recall: Z-1816-2013 · Reported August 7, 2013

    Enforcement

    Recall Number
    Z-1816-2013
    Event ID
    65669
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 7, 2013
    Initiation Date
    October 12, 2012
    Classification Date
    July 29, 2013
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

    Reason

    It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined that the incorrect insert was used which indicates that the device is MR Safe, when it is actually MR Conditional.

    Code Info

    Part Number 390.007, Lot Number 6800599

    Distribution

    US Distribution including the states of CA, MN, NC and TN.

    Quantity

    8