Events

Recall of TriNex Healing Abutment

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Southern Implants, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66569
  • Event Risk Class
    Class 2
  • Event Number
    Z-0382-2014
  • Event Initiated Date
    2013-09-13
  • Event Date Posted
    2013-11-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122633
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Abutment, implant, dental, endosseous - Product Code NHA
  • 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 customersupport@keystonedental.com. For questions regarding this recall call 866-903-9272.

Device

TriNex Healing Abutment
  • Model / Serial
    Lot # 2676021303
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Guatemala, Taiwan.
  • Product 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.
  • Manufacturer
    Southern Implants, Inc

Manufacturer

Southern Implants, Inc
  • Manufacturer Address
    Southern Implants, Inc, 5 Holland Ste 209, Irvine CA 92618-2576
  • Manufacturer Parent Company (2017)
    Southern Implants Inc.
  • Source
    USFDA