BEUDAMED
    FDA Enforcement Class II Terminated

    Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument

    Recall: Z-1028-2022 · Reported May 11, 2022

    Enforcement

    Recall Number
    Z-1028-2022
    Event ID
    89983
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    restor3d Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 11, 2022
    Initiation Date
    March 30, 2022
    Classification Date
    April 29, 2022
    Termination Date
    August 28, 2023
    Address
    311 W Corporation St, N/A, Durham, NC, 27701-2409, United States

    Description

    Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument

    Reason

    During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.

    Code Info

    Model: 6101-22200818; Lot: 2022010035; UDI: 00840097501598

    Distribution

    US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.

    Quantity

    9 units