BEUDAMED
    FDA Recall Terminated

    Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-image scans.

    Recall: Z-2886-2020 · Initiated July 17, 2020

    Recall

    Recall Number
    Z-2886-2020
    Event Number
    86113
    Firm
    Materialise N.V. Technologielaan 15 Heverlee Belgium
    FEI Number
    3003998208
    Product Code
    KWS
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    July 17, 2020
    Terminated
    December 23, 2020

    Description

    Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-image scans.

    Reason

    The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side.

    Action

    The firm, materialise, sent Recall letters dated 17 July 2020 informing customers of the issue. This letter informs the customer that Materialise has corrected the Shoulder Case Planning Report in the SurgiCase online system. If you have any questions, contact Global Quality and Regulatory Manager Medical, at 734-259-7017 or email: [email protected].

    Distribution

    Nationwide distribution to: US including PR and International to UK and Australia.

    Quantity

    128