BEUDAMED
    FDA Enforcement Class II Ongoing

    ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266

    Recall: Z-1497-2024 · Reported April 17, 2024

    Enforcement

    Recall Number
    Z-1497-2024
    Event ID
    94278
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Synovo Production
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 17, 2024
    Initiation Date
    May 30, 2023
    Classification Date
    April 8, 2024
    Address
    1501 N Harbor Blvd Ste 209, N/A, Fullerton, CA, 92835-3803, United States

    Description

    ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266

    Reason

    Medical device components were marketed without FDA clearance

    Code Info

    UDI/REF Number: 00814193025906/01-02-4254; 00814193025913/01-02-4456; 00814193025920/01-02-4558; 00814193025937/01-02-4760; 00814193025968/01-02-4962; 00814193025944/01-02-5164; 00814193025951/01-02-5266; REF Number/Lot Number: 01-02-4254 01024254FNN612, 01-02-4254 01024254FNN613, 01-02-4254 01024254GNN614, 01-02-4254 01024254FNN620, 01-02-4254 01024254GNN623, 01-02-4254 01024254FNN644, 01-02-4254 01024254NN651, 01-02-4254 01024254NN652, 01-02-4254 01024254NN741, 01-02-4456 01024456ENN613, 01-02-4456 01024456FNN614, 01-02-4456 01024456ENN620, 01-02-4456 01024456FNN620, 01-02-4456 01024456FNN623, 01-02-4456 01024456ENN644, 01-02-4456 01024456FNN644, 01-02-4456 01024456ENN650, 01-02-4456 01024456FNN650, 01-02-4456 01024456NN651, 01-02-4456 01024456NN652, 01-02-4456 01024456NN656, 01-02-4456 01024456NN728, 01-02-4458 01024458NN651, 01-02-4458 01024458NN652, 01-02-4558 01024558FNN614, 01-02-4558 01024558FNN623, 01-02-4558 01024558NN629, 01-02-4558 01024558HNN686, 01-02-4558 01024558HNN692, 01-02-4558 01024558JNN698, 01-02-4760 01024760FNN614, 01-02-4760 01024760ENN616, 01-02-4760 01024760ENN620, 01-02-4760 01024760FNN620, 01-02-4760 01024760FNN623, 01-02-4760 01024760ENN625, 01-02-4760 01024760FNN644, 01-02-4760 01024760NN651, 01-02-4760 01024760NN652, 01-02-4760 01024760NN654, 01-02-4760 01024760NN656, 01-02-4760 01024760HNN698, 01-02-4760 01024760HNN728, 01-02-4760 01024760HNN741, 01-02-4962 01024962FNN614, 01-02-4962 01024962ENN616, 01-02-4962 01024962FNN622, 01-02-4962 01024962NN624, 01-02-4962 01024962NN628, 01-02-4962 01024962NN645, 01-02-4962 01024962ENN654, 01-02-4962 01024962NN668, 01-02-4962 01024962NN670, 01-02-4962 01024962HNN686, 01-02-4962 01024962HNN723, 01-02-4962 01024962NN734, 01-02-4962 01024962NN735, 01-02-5164 01025164ENN614, 01-02-5164 01025164ENN620, 01-02-5164 01025164ENN622, 01-02-5164 01025164NN634, 01-02-5164 01025164NN649, 01-02-5164 01025164NN656, 01-02-5164 01025164NN669, 01-02-5164 01025164GNN678, 01-02-5164 01025164GNN680, 01-02-5164 01025164GNN691, 01-02-5164 01025164HNN695, 01-02-5164 01025164HNN697, 01-02-5164 01025164JNN733, 01-02-5164 01025164JNN743, 01-02-5266 01025266NN639, 01-02-5266 01025266NN654, 01-02-5266 01025266NN656, 01-02-5266 01025266CNN664, 01-02-5266 01025266CNN670, 01-02-5266 01025266CNN691, 01-02-5266 01025255CNN692, 01-02-5266 01025266DNN698, 01-02-5266 01025266ENN733,

    Distribution

    US Nationwide distribution in the state of WA.

    Quantity

    1681 units