BEUDAMED
    FDA Enforcement Class II Terminated

    Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. 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-1560-2014 · Reported May 14, 2014

    Enforcement

    Recall Number
    Z-1560-2014
    Event ID
    67711
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 14, 2014
    Initiation Date
    March 11, 2014
    Classification Date
    May 6, 2014
    Termination Date
    August 14, 2017
    Address
    4024 Stirrup Creek Dr, N/A, Durham, NC, 27703-9000, United States

    Description

    Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. 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

    Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

    Code Info

    Product Code X-4981M4 - Lot 02J0800451

    Distribution

    Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.

    Quantity

    32,271 ea.