BEUDAMED
    FDA Recall Terminated

    Closed knot pusher REF 902813, Biomet Sports Medicine, Warsaw, IN. The device is intended to push knots down a limb of suture.

    Recall: Z-0059-2011 · Initiated August 2, 2010

    Recall

    Recall Number
    Z-0059-2011
    Event Number
    56589
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HXO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 2, 2010
    Posted
    October 14, 2010
    Terminated
    August 20, 2012
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Closed knot pusher REF 902813, Biomet Sports Medicine, Warsaw, IN. The device is intended to push knots down a limb of suture.

    Reason

    The firm has received four complaints that the closed knot pusher is missing a radius which contributes to sutures being cut during surgery.

    Action

    Biomet Sports Medicine sent URGENT MEDICAL DEVICE RECALL NOTICES dated 8/2/2010 to its customers and distributors. The notices stated that the use of the device should be discontinued and the products returned to Biomet. Healthcare professionals and consumers were to report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online at www.fda.gov/MedWatch/report.htm, by regular mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or by phone at (800)FDA-1088 or Fax (800)FDA-0178. Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8AM to 5PM.

    Distribution

    Worldwide Distribution - USA, including FL, NY, VA, CA, GA, AL, PA, MI, LA, KS, SD, KY, TX, AR, and WV, and the countries of Belgium, Italy, Argentina, Poland, Netherlands, Turkey and Portugal.

    Quantity

    101