BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.

    Recall: Z-2345-2015 · Reported August 12, 2015

    Enforcement

    Recall Number
    Z-2345-2015
    Event ID
    71659
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Anspach Effort, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 12, 2015
    Initiation Date
    July 1, 2015
    Classification Date
    August 5, 2015
    Termination Date
    December 14, 2016
    Address
    4500 Riverside Dr, N/A, Palm Beach Gardens, FL, 33410-4235, United States

    Description

    Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.

    Reason

    Saw head separated from the drive unit or began to come loose.

    Code Info

    Serial numbers: 100067, 100076, 100371, 100372, 100063, 100065, 100069, 100076, and 100055; Foreign: Item number 530.710 Serial numbers: 100020, 100026, 100039, 100248, 100254, 100257, 100263, 100265, 100269, 100270, 100293, 100296, 100307, 100313, 100315, 100339, and 100340.

    Distribution

    Worldwide Distribution - US Distribution to the states of : AR, LA, OH, and WA., and the countries of : China, France, Italy, Russia, South Africa, Switzerland, and United Kingdom.

    Quantity

    360 handpieces (Currently there are 9 affected units remaining in the US and 17 units OUS all others were reworked)