BEUDAMED
    FDA Recall 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 · Initiated December 16, 2019

    Recall

    Recall Number
    Z-1127-2020
    Event Number
    84694
    Firm
    Nextremity Solutions
    FEI Number
    3009540749
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 16, 2019
    Terminated
    September 8, 2020
    Address
    6210 N Buffalo St, Warsaw, IN, 46580

    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.

    Action

    On December 16, 2019, the firm notified customers and distributors via recall notification letter and e-mail. The notification instructed return of all product with the specified lot number. If customers have any questions, please call customer service at 574-371-3071 between 8AM-5PM EST, Monday thru Friday. Alternatively, questions may be emailed to [email protected].

    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