BEUDAMED
    FDA Recall Terminated

    Anspach Single Use, Sterile Bone Cutting Burrs

    Recall: Z-1008-2007 · Initiated May 18, 2007

    Recall

    Recall Number
    Z-1008-2007
    Event Number
    37977
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    HBB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 18, 2007
    Posted
    July 11, 2007
    Terminated
    January 17, 2009
    Address
    4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235

    Description

    Anspach Single Use, Sterile Bone Cutting Burrs

    Reason

    The white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product.

    Action

    The firm issued a recall letter on May 18, 2007, to its consignee, advising them of the recall. Consignees were asked to screen their inventory for the recalled devices and complete an accompanying product replacement form. The firm will replace all returned product within 30 days.

    Distribution

    World wide-Distributed throughout the United States and to Puerto Rico, Canada, Mexico, Japan, Lithuania, Cyprus, Austrailia, England, Sweden, Bahamas, Korea, Germany, Switzerland, Malaysia, Iceland, Portugal, Singapore, Poland, Hungary, Thailand, Austria, Israel, Belgium, Egypt, South Africa, Netherlands, India, Syria, Kenya, Italy, Czech Republic, Jamaica, Columbia, Argentina, Honduras, Saudi Arabia, Greece, Finland, Taiwan, Republic of China, Lebanon, Denmark, France, Hong Kong, Philippines, Venezuela, Argintina, and the United Kingdom.

    Quantity

    1,962,123