BEUDAMED
    FDA Enforcement Class II Ongoing

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.

    Recall: Z-2114-2021 · Reported July 28, 2021

    Enforcement

    Recall Number
    Z-2114-2021
    Event ID
    88126
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 28, 2021
    Initiation Date
    June 29, 2021
    Classification Date
    July 22, 2021
    Address
    2320 Nw 66th Ct, N/A, Gainesville, FL, 32653-1630, United States

    Description

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.

    Reason

    Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

    Code Info

    All serial numbers. UDI-DI numbers: 10885862013682, 10885862013699, 10885862013705, 10885862013712, 10885862013729

    Distribution

    Distribution US nationwide.

    Quantity

    89,050 total