BEUDAMED
    FDA Recall 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 · Initiated June 17, 2016

    Recall

    Recall Number
    Z-2743-2016
    Event Number
    74613
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    NOV
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    June 17, 2016
    Terminated
    November 7, 2017
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    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.

    Action

    Integra sent an Urgent Voluntary Medical Device Recall letter and recall acknowledgment and return form dated June 17, 2016 to their customers via traceable courier. Customers were asked to review their inventory and complete the attached form. Customers with questions should contact Customer Service at 1-800-654-2873. For questions regarding this recall call 717-840-3431.

    Distribution

    Nationwide distribution

    Quantity

    6,729 units