BEUDAMED
    FDA Recall Open, Classified

    Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1883080EM, Rotatable Fusion Blade, Quadcut 3.0 mm x 13 cm; (2) REF 1883480EM, Rotatable Fusion Blade, Quadcut, 3.4 mm x 13 cm; (3) REF 1884006EM, Rotatable Fusion Blade, RAD 40; (4) REF 1884012EM, Rotatable Fusion Blade, RAD 12; (5) REF 1884080EM, Rotatable Fusion Blade, Tricut, 13 cm; (6) REF 1884380EM, Rotatable Fusion Blade, Quadcut, 4.3 mm x 13 cm.

    Recall: Z-0157-2022 · Initiated August 31, 2021

    Recall

    Recall Number
    Z-0157-2022
    Event Number
    88586
    Firm
    Medtronic Xomed, Inc.
    FEI Number
    1045254
    Product Code
    HAW
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 31, 2021
    Posted
    October 21, 2021
    Address
    6743 Southpoint Dr N, Jacksonville, FL, 32216-6218

    Description

    Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1883080EM, Rotatable Fusion Blade, Quadcut 3.0 mm x 13 cm; (2) REF 1883480EM, Rotatable Fusion Blade, Quadcut, 3.4 mm x 13 cm; (3) REF 1884006EM, Rotatable Fusion Blade, RAD 40; (4) REF 1884012EM, Rotatable Fusion Blade, RAD 12; (5) REF 1884080EM, Rotatable Fusion Blade, Tricut, 13 cm; (6) REF 1884380EM, Rotatable Fusion Blade, Quadcut, 4.3 mm x 13 cm.

    Reason

    There was an increase in complaints related to tip breaks and wobble/vibration.

    Action

    The recalling firm issued letters dated 8/13/2021 on 8/31/2021 via USPS. The letter explained the reason for recall, risk to patient, and the actions to be taken. The consignee was requested to review their inventory of Medtronic blades against the list of affected products enclosed with the letter and to quarantine them. All unused, affected devices are to be returned to Medtronic by completing the Customer Confirmation form and returning it via FAX or email. Once completed, Customer Care will provide return instructions and issue a replacement for the returned product.

    Distribution

    Worldwide distribution - US Nationwide, including PR. There was also government/military distribution and the countries of Australia, Austria, Bahrain, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kuwait, Latvia, Libya, Luxembourg, Macao, Malaysia, Mauritius, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Viet Nam.

    Quantity

    274,991 total devices