BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1983-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1983-2014
    Event ID
    68496
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Anspach Effort, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 9, 2014
    Initiation Date
    May 8, 2014
    Classification Date
    July 3, 2014
    Termination Date
    January 29, 2016
    Address
    4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235, United States

    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.

    Code Info

    DFU: 18-0047: Revisions A & B 18-0074: Revision A; and 18-0105: Revisions A. Operating Manuals: 19-0010: Revisions A, and 19-0013: Revisions A, B, & C.

    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