BEUDAMED
    FDA Recall Terminated

    Integra Cadence Total Ankle System

    Recall: Z-1192-2017 · Initiated January 20, 2017

    Recall

    Recall Number
    Z-1192-2017
    Event Number
    76290
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    HSN
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    January 20, 2017
    Posted
    February 11, 2017
    Terminated
    March 30, 2017
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Integra Cadence Total Ankle System

    Reason

    Posterior tibial fractures have been reported.

    Action

    The firm intends to update the surgical technique only. No product will be returned. US and non-US consignees were notified by letter delivered by traceable fax or e-mail on 01/20/2017.

    Distribution

    Nationwide

    Quantity

    944 units