BEUDAMED
    FDA Enforcement Class II Terminated

    Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.

    Recall: Z-1127-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1127-2020
    Event ID
    84694
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nextremity Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2020
    Initiation Date
    December 16, 2019
    Classification Date
    February 10, 2020
    Termination Date
    September 8, 2020
    Address
    6210 N Buffalo St, Warsaw, IN, 46580, United States

    Description

    Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.

    Reason

    The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate.

    Code Info

    Lot M1502

    Distribution

    Domestic distribution to AL, CA, FL, GA, ID, IL, IA, KY, LA, ME, MA, MI, MN, MS, NE, NJ, NY, OH ,OK, OR, TX, and WA.

    Quantity

    40