BEUDAMED
    FDA Recall Terminated

    OSTEOMATRIX bone graft substitute. OMG10. Osteomatrix is provided sterile for single patient use.

    Recall: Z-1677-2011 · Initiated January 31, 2011

    Recall

    Recall Number
    Z-1677-2011
    Event Number
    57926
    Firm
    Biostructures, LLC
    FEI Number
    3005449756
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 31, 2011
    Posted
    March 16, 2011
    Terminated
    March 17, 2011
    Address
    3700 Campus Dr, Ste 204, Newport Beach, CA, 92660-2603

    Description

    OSTEOMATRIX bone graft substitute. OMG10. Osteomatrix is provided sterile for single patient use.

    Reason

    The OsteoMatrix Synthetic Bone Graft Composite Instructions for Use document, P4G10A/Rev. 01 had language that was not consistent with the cleared indications.

    Action

    An email was sent on 06/15/2010 to the firm's distributors that had products with lot #0809D110 or lot #0307I208 in their possesion. The email was in regards to the distributors' OMG10 granule inventory. The distributors need to return all the recalled granule inventory to be swapped out for new inventory.

    Distribution

    Products were distributed to 6 consignees that were located in Michigan, Ohio, Maryland, California, Texas, and Utah.

    Quantity

    248 units