BEUDAMED
    FDA Enforcement Class II Ongoing

    Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System

    Recall: Z-1776-2022 · Reported September 28, 2022

    Enforcement

    Recall Number
    Z-1776-2022
    Event ID
    90753
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Paragon 28, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 28, 2022
    Initiation Date
    July 13, 2022
    Classification Date
    September 22, 2022
    Address
    14445 Grasslands Dr, N/A, Englewood, CO, 80112-7062, United States

    Description

    Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System

    Reason

    Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.

    Code Info

    UDI-DI: 00889795114228, Lot: 5007499

    Distribution

    US Nationwide distribution in the states of AZ, IN, LA, NJ, TX, WA, NY, MD, WI, OK, KY, MI, OH, CA, FL, KS, PA.

    Quantity

    145