BEUDAMED
    FDA Enforcement Class II Terminated

    P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only

    Recall: Z-0662-2020 · Reported December 18, 2019

    Enforcement

    Recall Number
    Z-0662-2020
    Event ID
    84234
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Paragon 28, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 18, 2019
    Initiation Date
    September 28, 2018
    Classification Date
    December 10, 2019
    Termination Date
    August 20, 2020
    Address
    4B Inverness Ct E Ste 280, N/A, Englewood, CO, 80112-5329, United States

    Description

    P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only

    Reason

    It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could result in improper preparation of the surgical site causing delays in surgery.

    Code Info

    Lot # BR4108

    Distribution

    AR, CA, CO, CT, DC, DE,FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MT, MS, NC, NE, NY, NJ, NV, OH, OR, PA, SC, SD, TN, TX, VT, WA, WI, WY OUS: Australia & Israel

    Quantity

    64 Wedge Systems