BEUDAMED
    FDA Recall Terminated

    Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 8 mm diameter, 130 mm length, non-sterile, catalog no. 4309-08-13 (00-4309-008-13).

    Recall: Z-1271-06 · Initiated June 16, 2006

    Recall

    Recall Number
    Z-1271-06
    Event Number
    35783
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    HWT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 16, 2006
    Posted
    July 27, 2006
    Terminated
    December 5, 2007
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 8 mm diameter, 130 mm length, non-sterile, catalog no. 4309-08-13 (00-4309-008-13).

    Reason

    During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal.

    Action

    U.S. and international distributors were notified of the recall via letter dated 6/30/2006 to check customer inventories and to return recalled product to the firm. Trial implants were redesigned and reworked to eliminate the problem.

    Distribution

    Nationwide and worldwide including Australia, Canada, Germany, Italy and Spain.

    Quantity

    324 total