BEUDAMED
    FDA Recall Terminated

    00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty

    Recall: Z-0395-2013 · Initiated October 10, 2010

    Recall

    Recall Number
    Z-0395-2013
    Event Number
    63066
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    HWT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 10, 2010
    Posted
    November 19, 2012
    Terminated
    April 30, 2014
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty

    Reason

    Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. To reduce incidence of sub-optimal fit between provisional femoral heads and the mat

    Action

    The firm, Zimmer, sent notification by email to consignees beginning October 10, 2012 with a follow-up letter titled "URGENT MEDICAL DEVICE CORRECTION" dated October 16, 2012 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to complete a spreadsheet of current users and contact information and immediately provide this information via email to: [email protected], and review and become familiar with the content and recommendations of the attached letter sent to the customers. For questions call 1-877-946-2761.

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America.

    Quantity

    56,516 all lots, all sizes