BEUDAMED
    FDA Enforcement Class II Terminated

    10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur

    Recall: Z-0219-2015 · Reported November 26, 2014

    Enforcement

    Recall Number
    Z-0219-2015
    Event ID
    69685
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 26, 2014
    Initiation Date
    October 29, 2014
    Classification Date
    November 14, 2014
    Termination Date
    December 18, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur

    Reason

    The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.

    Code Info

    part number: 456.316S, lot number: 7782247

    Distribution

    US Distribution in the states of: AK, FL, OH, OK, and TX.

    Quantity

    6