BEUDAMED
    FDA Recall Terminated

    Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

    Recall: Z-0382-2014 · Initiated September 13, 2013

    Recall

    Recall Number
    Z-0382-2014
    Event Number
    66569
    Firm
    Southern Implants, Inc
    FEI Number
    3003845138
    Product Code
    NHA
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    September 13, 2013
    Posted
    November 22, 2013
    Terminated
    January 21, 2014
    Address
    5 Holland, Ste 209, Irvine, CA, 92618-2576

    Description

    Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

    Reason

    Southern Implants is recalling the Tri-Nex healing abutment because the package was incorrectly labeled and packaged as the Tri-Nex healing abutment, 05.0 mm x 5 mm height (HA-L-50-5). The package contains the Tri-Nex healing abutment 05.0 mm x 6.0 mm Flare x 5 mm Height (HA-L-50W-5).

    Action

    Southern Implants, Inc. sent an Urgent Product Action letter dated September 11, 2013, to all affected customers. The letter identiied the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out the customer response form and fax/email the completed form to Customer Support at (866) 903-9272 or [email protected]. For questions regarding this recall call 866-903-9272.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Guatemala, Taiwan.

    Quantity

    197 units