BEUDAMED
    FDA Enforcement Class II Ongoing

    Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    Recall: Z-1521-2021 · Reported May 12, 2021

    Enforcement

    Recall Number
    Z-1521-2021
    Event ID
    87577
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Oto Med Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 12, 2021
    Initiation Date
    December 7, 2020
    Classification Date
    April 30, 2021
    Address
    1090 Empire Dr, N/A, Lake Havasu City, AZ, 86404-2429, United States

    Description

    Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    Reason

    During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.

    Code Info

    UDI Code: 00850000126077 Lot Numbers: 019120 G(2) 0712119 G(2) 0912118 G(2) 1012119 G(2)

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of MN, IL, PA, WI, GA, SD, FL, AR, MA, AZ, TX, MO, NC, CA, UT, DE, OR, IN, CO, AL, OH, NY, WA, DC, TN, NH, VT, VA, SC, MI, WI, MS, IA, NJ, MD, KS, CT, LA, ME, KY, HI, TN, RI, NV, ID and the countries of Argentina, Brazil, Colombia, Chile, Hong Kong, South Africa, United Arab Emirates, Taiwan, Canada, India.

    Quantity

    415 devices