BEUDAMED
    FDA Recall Terminated

    Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh.

    Recall: Z-0446-2012 · Initiated April 27, 2011

    Recall

    Recall Number
    Z-0446-2012
    Event Number
    59231
    Firm
    OSTEOPORE INTERNATIONAL PTE LTD 10, SCIENCE PARK ROAD THE ALPHA, #02-28 SINGAPORE Singapore
    FEI Number
    3007303685
    Product Code
    GXP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 27, 2011
    Posted
    January 11, 2012
    Terminated
    June 6, 2012

    Description

    Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh.

    Reason

    Product sterility may be compromised.

    Action

    Osteopore sent an Urgent Voluntary Product Recall notice to their consignees by letter dated April 27, 2011.

    Distribution

    Nationwide distribution - one distributor in TX.

    Quantity

    330