BEUDAMED
    FDA Recall Open, Classified

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Novation GXL Liner, 10 Deg Face, 28mm. Orthopedic hip implant component.

    Recall: Z-2131-2021 · Initiated June 29, 2021

    Recall

    Recall Number
    Z-2131-2021
    Event Number
    88126
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    LPH
    Status
    Open, Classified
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    June 29, 2021
    Posted
    July 22, 2021
    Address
    2320 Nw 66th Ct, Gainesville, FL, 32653-1630

    Description

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Novation GXL Liner, 10 Deg Face, 28mm. 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.

    Action

    The firm issued "URGENT MEDICAL DEVICE CORRECTION" letters dated 6/28/2021 via email on 6/29/2021 that were addressed to the attention of Exactech Agents, Representatives, and Distributors in possession of affected products.

    Distribution

    Distribution US nationwide.

    Quantity

    89,050 total