BEUDAMED
    FDA Recall 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 · Initiated September 28, 2018

    Recall

    Recall Number
    Z-0662-2020
    Event Number
    84234
    Firm
    Paragon 28, Inc.
    FEI Number
    3008650117
    Product Code
    PLF
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    September 28, 2018
    Posted
    December 10, 2019
    Terminated
    August 20, 2020
    Address
    4B Inverness Ct E, Ste 280, Englewood, CO, 80112-5329

    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.

    Action

    On September 19th, 2018 Paragon 28 issued a Recall Letter to consignees via email and physical mail. The letter informed consignees of the product mislabeling issue. They were instructed to immediately take the following actions: 1. Review inventory of the TITAN 3D Wedge implants to determine if they possess affected product. 2. If they possess the affected product, return product to Paragon 28 for disposition 3. Regardless, if they have or do not have affected recall product, complete and return an acknowledgement form to Paragon 28

    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