BEUDAMED
    FDA Recall Terminated

    Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.

    Recall: Z-1841-2016 · Initiated March 11, 2016

    Recall

    Recall Number
    Z-1841-2016
    Event Number
    74079
    Firm
    Integra York PA, Inc
    FEI Number
    2518040
    Product Code
    GDZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 11, 2016
    Posted
    May 31, 2016
    Terminated
    April 17, 2017
    Address
    589 Davies Dr, York, PA, 17402-8630

    Description

    Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.

    Reason

    One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.

    Action

    Integra mailed out an Urgent: Voluntary Medical Device Recall letter to customers informing them to evaluate their inventory for the affected product. If product was shipped to customers, they were asked to identify their customers and to stop shipping immediately. Integra requested that customers complete the attached form that was sent with the notification indicating whether or not they had the affected product on hand and customer service will contact them to provide a Return Authorization number for the product's return. Customers could reach Customer Service at 866-854-8300.

    Distribution

    Worldwide distribution. US nationwide, Mexico, and Korea.

    Quantity

    678 Chisel Blade Holders