BEUDAMED
    FDA Enforcement Class II Terminated

    Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or Ushaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

    Recall: Z-1295-2014 · Reported April 2, 2014

    Enforcement

    Recall Number
    Z-1295-2014
    Event ID
    67733
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 2, 2014
    Initiation Date
    March 11, 2014
    Classification Date
    March 25, 2014
    Termination Date
    August 15, 2017
    Address
    2917 Weck Dr., N/A, Research Triangle Park, NC, 27709, United States

    Description

    Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or Ushaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

    Reason

    The products are being recalled because they did not meet minimum needle attachment strength requirements.

    Code Info

    Product Code: X-4981M4, Lot number: 02J0800451

    Distribution

    Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland

    Quantity

    Total 32,271 ea.