BEUDAMED
    FDA Enforcement Class II Terminated

    OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

    Recall: Z-2188-2020 · Reported June 10, 2020

    Enforcement

    Recall Number
    Z-2188-2020
    Event ID
    85529
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Osteomed, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2020
    Initiation Date
    April 2, 2020
    Classification Date
    May 29, 2020
    Termination Date
    May 5, 2021
    Address
    3885 Arapaho Rd, N/A, Addison, TX, 75001-4314, United States

    Description

    OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

    Reason

    Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

    Code Info

    LOT 17060509, 17102710, 17040533, 17051911, 1126986, 1128789, 1134232, 1136330, 1144043 and 1142210

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA. MA, MD, ME. MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY and the countries of AUSTRALIA, ITALY, KOREA, MALAYSIA, PERU, SINGAPORE and THAILAND.

    Quantity

    1724