BEUDAMED
    FDA Enforcement Class II Terminated

    Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T

    Recall: Z-1167-2019 · Reported April 24, 2019

    Enforcement

    Recall Number
    Z-1167-2019
    Event ID
    82377
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2019
    Initiation Date
    March 8, 2019
    Classification Date
    April 16, 2019
    Termination Date
    May 15, 2020
    Address
    311 Enterprise Dr, N/A, Plainsboro, NJ, 08536-3344, United States

    Description

    Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T

    Reason

    The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU

    Code Info

    180078 182903 183670 190799

    Distribution

    Distributors in AL, CA, CT, FL, GA, HI, IA, ID, KS, KY, MD, MI, MO, MT, NC, NE, NJ, NM, NY, OH, OK,PA, TX, VA, WA, and WI.

    Quantity

    2029