BEUDAMED
    FDA Recall Terminated

    K3 Engine File G-Pack, Product: Endodontic Pulp Canal File, Part Number: 830-9925. For use in root canal preparation.

    Recall: Z-1172-2012 · Initiated August 1, 2008

    Recall

    Recall Number
    Z-1172-2012
    Event Number
    61224
    Firm
    Ormco Corporation
    FEI Number
    2016150
    Product Code
    EKS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 1, 2008
    Posted
    March 6, 2012
    Terminated
    March 8, 2012
    Address
    1332 S Lone Hill Ave, Glendora, CA, 91740

    Description

    K3 Engine File G-Pack, Product: Endodontic Pulp Canal File, Part Number: 830-9925. For use in root canal preparation.

    Reason

    A recall was initiated because SybronEndo has confirmed that the K3 Engine File G-Pack has label packaging and file mis-marking error.

    Action

    A recall communication was initiated on 07/31/2008 with SybronEndo forwarding an Urgent Medical Device Recall letter (via USPS 1st class mail) to all their customers who purchased the K3 Engine File G-Pack (Part No. 830-9925). The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to contact SybronEndo Customer Care at (800) 346-3636 directly to handle the arrangements of a quick return and replacement. Customers were instructed to complete the Return Form and return any affected product in their inventory.

    Distribution

    Worldwide Distribution -- US, including the territory of St. Thomas, and countries of Australia, Canada, New Zealand, China, Singapore, India, and Chile.

    Quantity

    199 units