BEUDAMED
    FDA Enforcement Class II Ongoing

    restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System

    Recall: Z-1569-2025 · Reported April 23, 2025

    Enforcement

    Recall Number
    Z-1569-2025
    Event ID
    96606
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Conformis Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 23, 2025
    Initiation Date
    March 25, 2025
    Classification Date
    April 15, 2025
    Address
    600 Research Dr, Wilmington, MA, 01887-4437, United States

    Description

    restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System

    Reason

    The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.

    Code Info

    Model Number: HDL-060-C22L-000101 UDI-DI: M572HDL060C22L011. Lot: 1788258

    Distribution

    US Nationwide distribution in the states of CA, FL, NV, TN.

    Quantity

    16