BEUDAMED
    FDA Recall Open, Classified

    ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844

    Recall: Z-1007-2024 · Initiated December 15, 2023

    Recall

    Recall Number
    Z-1007-2024
    Event Number
    93804
    Firm
    Globus Medical, Inc.
    FEI Number
    3004142400
    Product Code
    OLO
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    December 15, 2023
    Posted
    February 7, 2024
    Address
    2560 General Armistead Ave, Audubon, PA, 19403-5214

    Description

    ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844

    Reason

    Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilization. There is an increased risk for infection, inflammation, local toxicity, systemic toxicity, sensitivity, and cross-contamination.

    Action

    On December 15, 2023, the firm began to notify customers by phone. On January 9, 2024, firm began following up with letters. Customers were instructed to immediately return affected cannulas to Globus Medical and complete the letter's Response Card. For recall-related questions, please contact Globus Medical Complaint Handling Unit at [email protected]. Fax: 610-300-1342.

    Distribution

    Worldwide - US Nationwide and the countries of Australia, Austria, Belgium, Czech Republic, Germany, India, Indonesia, Ireland, Italy, Japan, Malaysia, Netherlands, Poland, Saudi Arabia, Singapore, Spain, United Arab Emirates, United Kingdom.

    Quantity

    570