BEUDAMED
    FDA Recall Terminated

    OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

    Recall: Z-2184-2020 · Initiated April 2, 2020

    Recall

    Recall Number
    Z-2184-2020
    Event Number
    85529
    Firm
    Osteomed, LLC
    FEI Number
    2027754
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    April 2, 2020
    Posted
    May 29, 2020
    Terminated
    May 5, 2021
    Address
    3885 Arapaho Rd, Addison, TX, 75001-4314

    Description

    OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - 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.

    Action

    On 04/02/2020, an URGENT Medical Device Recall letter was sent to all consignees affected by the recall. OsteoMed has requested that affected customers: (1) review this letter in full, review current inventory, and complete and return the Acknowledgement and Receipt Form via email or fax; and (2) return unused inventory via Federal Express (using OsteMed account)

    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

    436