BEUDAMED
    FDA Recall Terminated

    Bone Screw 5.5MM X 45MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway, Parsippany, NJ 070454 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws.

    Recall: Z-2290-2009 · Initiated April 2, 2009

    Recall

    Recall Number
    Z-2290-2009
    Event Number
    51730
    FEI Number
    2242816
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 2, 2009
    Posted
    September 22, 2009
    Terminated
    September 23, 2009
    Address
    EBI, L.P. 100 Interpace Pkwy, Parsippany, NJ, 07054-1149

    Description

    Bone Screw 5.5MM X 45MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway, Parsippany, NJ 070454 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws.

    Reason

    Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.

    Action

    The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail. Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure. An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items. On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers. Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.

    Distribution

    Worldwide - US -NY, NJ, MI, MD, FL, GA, PR, MN, SD, OK, TX,, LA, CA, PA, OH, NV, HI, ME, NC, KS, UT, CO, TN, WV, VA, and WA. Foreign: Brazil, Colombia, Denmark, Germany, Finland, Greece, Italy, Japan, The Netherlands, Switzerland, Sweden, Portugal, Spain, United Kingdom, Saudi Arabia, and Trinidad.

    Quantity

    10