BEUDAMED
    FDA Recall Terminated

    EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless 48mm dia incl. central hole cover; 02200050 /EcoFit cup cementless 50mm dia incl. central hole cover; 02200052 /EcoFit cup cementless 52mm dia incl. central hole cover; 02200054 /EcoFit cup cementless 54mm dia incl. central hole cover; 02200056 /EcoFit cup cementless 56mm dia incl. central hole cover; 02200058 /EcoFit cup cementless 58mm dia incl. central hole cover; 02200060 /EcoFit cup cementless 60mm dia incl. central hole cover; 02200062 /EcoFit cup cementless 62mm dia incl. central hole cover; 02200064 /EcoFit cup cementless 64mm dia incl. central hole cover; 02200066 /EcoFit cup cementless 66mm dia incl. central hole cover; 02200068 /EcoFit cup cementless 68mm dia incl. central hole cover;

    Recall: Z-2050-2021 · Initiated May 10, 2021

    Recall

    Recall Number
    Z-2050-2021
    Event Number
    88047
    Firm
    IMPLANTCAST GMBH Luneburger Schanze 26 Buxtehude Germany
    FEI Number
    3012523063
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 10, 2021
    Posted
    July 9, 2021
    Terminated
    November 18, 2022

    Description

    EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless 48mm dia incl. central hole cover; 02200050 /EcoFit cup cementless 50mm dia incl. central hole cover; 02200052 /EcoFit cup cementless 52mm dia incl. central hole cover; 02200054 /EcoFit cup cementless 54mm dia incl. central hole cover; 02200056 /EcoFit cup cementless 56mm dia incl. central hole cover; 02200058 /EcoFit cup cementless 58mm dia incl. central hole cover; 02200060 /EcoFit cup cementless 60mm dia incl. central hole cover; 02200062 /EcoFit cup cementless 62mm dia incl. central hole cover; 02200064 /EcoFit cup cementless 64mm dia incl. central hole cover; 02200066 /EcoFit cup cementless 66mm dia incl. central hole cover; 02200068 /EcoFit cup cementless 68mm dia incl. central hole cover;

    Reason

    A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A warning note is being added to instructions for use and surgical technique alerting users that the quality of bone in the patient (such as osteosclerosis) is an attributable factor.

    Action

    On May 10, 2021 Urgent Safety Information notices were emailed to customers who were asked to take the following action: 1. Read this safety information carefully and make sure all relevant departments and officeholders are informed about its content. 2. Keep this safety information. 3. Fill in and return the reply form. Customers with additional questions were encouraged to contact Wendy Ryan-Kettler at [email protected] On 17 May, 2017, a follow-up Medical Device Correction notice was emailed to customers who were asked to take the following additional actions: 4. Destroy the affected (previous) surgical technique and instruction for use (IFU) and replace them with the updated versions that accompanied this safety information.

    Distribution

    U.S. Nationwide distribution in the states of FL and TX.

    Quantity

    41 units (U.S.)