BEUDAMED
    FDA Enforcement Class II Ongoing

    Identity Imprint PS Tibial Tray Size 4: Lot 540287

    Recall: Z-1591-2024 · Reported April 24, 2024

    Enforcement

    Recall Number
    Z-1591-2024
    Event ID
    94288
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Conformis, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 24, 2024
    Initiation Date
    March 11, 2024
    Classification Date
    April 17, 2024
    Address
    600 Technology Park Dr # 400, Billerica, MA, 01821-4154, United States

    Description

    Identity Imprint PS Tibial Tray Size 4: Lot 540287

    Reason

    Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.

    Code Info

    Catalog Number: TPS-301-T04S; UDI#: M572TPS301T04S011, Lot number 540287

    Distribution

    US Nationwide distribution in the states of FL, KS and NH.

    Quantity

    3 units