BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0699-2016 · Initiated April 4, 2013

    Recall

    Recall Number
    Z-0699-2016
    Event Number
    72908
    Firm
    Smith & Nephew, Inc., Endoscopy Div.
    FEI Number
    1219602
    Product Code
    HWR
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    April 4, 2013
    Posted
    January 29, 2016
    Terminated
    March 22, 2021
    Address
    130 Forbes Blvd, Mansfield, MA, 02048

    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.

    Action

    Smith & Nephew sent an "Urgent-Product Recall 1st. Notification" dated April 3, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please inspect your inventory and locate all devices from the above listed product and lot numbers and quarantine them immediately. For further questions, please call (978) 749-1000.

    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