BEUDAMED
    FDA Recall Terminated

    Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.

    Recall: Z-1983-2014 · Initiated May 8, 2014

    Recall

    Recall Number
    Z-1983-2014
    Event Number
    68496
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    HSZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 8, 2014
    Posted
    July 3, 2014
    Terminated
    January 29, 2016
    Address
    4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235

    Description

    Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.

    Reason

    Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device.

    Action

    Customers were notified 05/08/2014 by a Return Receipt Requested letter from Anspach with an URGENT: Medical Device Labeling Correction announcement, REGARDING: STERRAD 100S Hydrogen Peroxide Gas Plasma Technology no longer recommended for sterilization of Anspach products. The letter identified the problem and actions to be taken by the customer. Customers were to complete and return the attached reply form. If the products were distributed further, then those customers should have been notified as well. Customers were to contact Anspach Customer Support at 1-800-327-6887 if they want copies of the revised labeling.

    Distribution

    Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI, WV, WY, and Hawaii, and the territories of Puerto Rico, US Virgin Island and Guam; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Cameroon, Canada, Chile, Costa Rica, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Grand Cayman, Hong Kong, India, Israel, Jamaica, Japan, Korea, Lithuania, Malaysia, Mexico, Nassau, Netherlands, Nigeria, Palestine, Panama, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, United Kingdom, and Venezuela.

    Quantity

    115,988 units