BEUDAMED
    FDA Recall Terminated

    Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.

    Recall: Z-0198-2014 · Initiated May 6, 2011

    Recall

    Recall Number
    Z-0198-2014
    Event Number
    65863
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    HBC
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    May 6, 2011
    Posted
    November 13, 2013
    Terminated
    January 28, 2016
    Address
    4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235

    Description

    Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.

    Reason

    Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of th

    Action

    The firm, Anspach Effort, Inc., sent an "Urgent Medical Device Labeling Correction" letter dated June 27, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Destroy or delete any items in their inventory immediately and replace with the attached revised Operating Manual, Product Catalog and/or Cutting Bur Chart. 2) Complete and return the attached Customer Reply Form indicating disposition of the labeling materials and confirming their receipt of this letter, and fax to 1-800-327-6661. 3) If they distributed any of the products to other services or facilities, please forward this information as appropriate. For additional copies, contact Anspach Customer Support at (800) 327-6887.

    Distribution

    Worldwide Distribution: USA Nationwide and the countries of: Egypt, India, Germany, Turkey, Canada, Saudi Arabia, Greece, United Kingdom, Cayman Islands, Kazakhstan, Republic of Korea, Taiwan, Hong Kong, China, Lebanon, Argentina, Denmark, Belgium, Netherlands, Mexico, France, Australia, Panama, Italy, Guam, United Arab Emirates, Israel, Polan, Venezuela, Austria, Hungary, Lithuania, Norway, Malaysia, Colombia, Costa Rica, Ecuador, Jamaica, Peru, Thailand, Italy, Czech Republic, Cameroon, South Africa, Portugal, Finland, Sweden, Nigeria, Bahamas, Cambodia, Dominican Republic, Switzerland, Chile, Singapore, Spain, Syrian Arab Republic, Jordan, Japan.

    Quantity

    2,020