BEUDAMED
    FDA Enforcement Class II Terminated

    Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use, sterile device used to treat acute Achilles tendon ruptures. The Achillon Suture System is a mini-invasive procedure indicated to teat acute Achilles tendon ruptures: Acute rupture of the Achill tendon(<10 days); Rupture located between 2 and 8 cm above calcaneum; Open or closed ruptures

    Recall: Z-2743-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2743-2016
    Event ID
    74613
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 14, 2016
    Initiation Date
    June 17, 2016
    Classification Date
    September 7, 2016
    Termination Date
    November 7, 2017
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344, United States

    Description

    Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use, sterile device used to treat acute Achilles tendon ruptures. The Achillon Suture System is a mini-invasive procedure indicated to teat acute Achilles tendon ruptures: Acute rupture of the Achill tendon(<10 days); Rupture located between 2 and 8 cm above calcaneum; Open or closed ruptures

    Reason

    Data from internal studies suggests there may be a potential that the secondary package seal integrity does not provide the level of sterility intended for Minimally Invasive Achilles Tendon Suture System Achillon.

    Code Info

    Model #'s 19700 and 19700ND

    Distribution

    Nationwide distribution

    Quantity

    6,729 units