BEUDAMED
    FDA Enforcement Class II Terminated

    Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument

    Recall: Z-0699-2016 · Reported February 10, 2016

    Enforcement

    Recall Number
    Z-0699-2016
    Event ID
    72908
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc., Endoscopy Div.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 10, 2016
    Initiation Date
    April 4, 2013
    Classification Date
    January 29, 2016
    Termination Date
    March 22, 2021
    Address
    130 Forbes Blvd, N/A, Mansfield, MA, 02048, United States

    Description

    Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument

    Reason

    Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.

    Code Info

    Lot Numbers: 50409038, 50404149, 50399964

    Distribution

    Worldwide Distribution - US Distribution to the states of : AK, AL, CA, CO, FL, IL, IN, MI, NE, NJ, NY, OH, OK, PA, SC, TN and TX., and to the countries of : Austria, Australia, Canada, Dubai, Great Britain, India, Italy, Korea, Malaysia, Netherlands, Portugal, Sweden, Switzerland, Singapore and South Africa.

    Quantity

    157