BEUDAMED
    FDA Enforcement Class II Ongoing

    NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shell) components.

    Recall: Z-0483-2025 · Reported November 27, 2024

    Enforcement

    Recall Number
    Z-0483-2025
    Event ID
    95598
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Novosource, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 27, 2024
    Initiation Date
    September 19, 2024
    Classification Date
    November 18, 2024
    Address
    2000 Hampton Ctr Ste C, N/A, Morgantown, WV, 26505-1704, United States

    Description

    NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shell) components.

    Reason

    Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted

    Code Info

    UDI-DI 00811382037849; Lot Number CER0023

    Distribution

    Florida, West Virginia

    Quantity

    1 unit