BEUDAMED
    FDA Recall Terminated

    POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 00587806538 POROUS PATELLA 41MM X 10MM - 00587806541

    Recall: Z-1950-2016 · Initiated April 15, 2016

    Recall

    Recall Number
    Z-1950-2016
    Event Number
    73536
    Firm
    Zimmer Trabecular Metal Technology, Inc.
    FEI Number
    3005751028
    Product Code
    MBH
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    April 15, 2016
    Terminated
    November 29, 2017
    Address
    10 Pomeroy Rd, Parsippany, NJ, 07054-3722

    Description

    POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 00587806538 POROUS PATELLA 41MM X 10MM - 00587806541

    Reason

    Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.

    Action

    Zimmer issued an Urgent Medical Device Recall Letter dated 4/15/2016.

    Distribution

    Nationwide and Foreign.

    Quantity

    19,884 total