BEUDAMED
    FDA Recall Terminated

    REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28X54 00701005428 REV. SHELL LINER 10D 28X56 00701005628 REV. SHELL LINER 10D 28X58 00701005828 REV. SHELL LINER 10D 28X60 00701006028 REV. SHELL LINER 10D 28X62 00701006228 REV. SHELL LINE 10D 28X66 00701006628 REV. SHELL LINER 20D 28X48 00702004828 REV. SHELL LINER 20D 28X50 00702005028 REV. SHELL LINER 20D 28X52 00702005228 REV. SHELL LINER 20D 28X54 00702005428 REV. SHELL LINER 20D 28X56 00702005628 REV. SHELL LINER 20D 28X60 00702006028 REV. SHELL LINER 20D 28X62 00702006228 REV. SHELL LINER 20D 28X66 00702006628

    Recall: Z-1954-2016 · Initiated April 15, 2016

    Recall

    Recall Number
    Z-1954-2016
    Event Number
    73536
    Firm
    Zimmer Trabecular Metal Technology, Inc.
    FEI Number
    3005751028
    Product Code
    JDI
    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

    REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28X54 00701005428 REV. SHELL LINER 10D 28X56 00701005628 REV. SHELL LINER 10D 28X58 00701005828 REV. SHELL LINER 10D 28X60 00701006028 REV. SHELL LINER 10D 28X62 00701006228 REV. SHELL LINE 10D 28X66 00701006628 REV. SHELL LINER 20D 28X48 00702004828 REV. SHELL LINER 20D 28X50 00702005028 REV. SHELL LINER 20D 28X52 00702005228 REV. SHELL LINER 20D 28X54 00702005428 REV. SHELL LINER 20D 28X56 00702005628 REV. SHELL LINER 20D 28X60 00702006028 REV. SHELL LINER 20D 28X62 00702006228 REV. SHELL LINER 20D 28X66 00702006628

    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