BEUDAMED
    FDA Recall Terminated

    The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LEO-1100-30-000 REV D.pdf.pdf, LEO-1100-40-000 REV D.pdf.pdf, LEO-110030100_REV D.pdf.pdf, LEO-110030110_REV D.pdf.pdf, LEO-110030120_REV D.pdf.pdf

    Recall: Z-1012-2018 · Initiated November 28, 2017

    Recall

    Recall Number
    Z-1012-2018
    Event Number
    79257
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    KWS
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    November 28, 2017
    Posted
    February 27, 2018
    Terminated
    March 27, 2020
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LEO-1100-30-000 REV D.pdf.pdf, LEO-1100-40-000 REV D.pdf.pdf, LEO-110030100_REV D.pdf.pdf, LEO-110030110_REV D.pdf.pdf, LEO-110030120_REV D.pdf.pdf

    Reason

    The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will cause the humeral stem to sit proud and may cause surgical delays.

    Action

    DePuy Orthopaedics, Inc. is voluntarily recalling 11 lots of the GLOBAL UNITE Platform Shoulder System. The device is being recalled because the screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will cause the humeral stem to sit proud and may cause surgical delays. Once the screw is properly assembled, there is no additional risk to the patient. Further distribution or use of the affected lots is to cease immediately.DePuy Orthopaedics, Inc. is not recommending prophylactic revision. The company recommends that surgeons discuss potential clinical implications and risks with symptomatic patients that received the affected lots and may have experienced a surgical delay. Please take the following actions: Please cease using the affected components immediately. Return affected devices: Medical facilities are to determine if any of the recalled devices are still on hand, and return affected devices immediately to their DePuy Synthes Sales Consultant or return them to DePuy Synthes Joint Reconstruction for credit following normal procedures. Reconciliation forms should be faxed to 574-371-4939. Note: The affected lots may be on consignment at your facility. Reconciliation Form: Complete the Reconciliation Form and return to your DePuy Synthes Sales Consultant, email to [email protected], or fax to 574-371-4939 within five (5) days of this notice. Records: Retain a copy of the completed Reconciliation Form in your files along with this notice. Additional Notifications: Notify surgeons at your facility by providing them with a copy of this notice to ensure surgeons are aware of this recall. Forward this notice to others in your facility that need to be informed.If any affected product has been forwarded to another facility, contact that facility immediately to communicate this field action with the facility/facilities. Maintain a copy of this notice wi

    Distribution

    Distribution Level: The device removal is extended to the companies US Distributors/Sales Offices and Medical Facilities that may have used, purchased, or received the affected devices. Approximately 53 units distributed to firm's international affiliates.

    Quantity

    85