Events

Recall of Device Recall Implant, Ext. Hex, tapered 12o CoAxis

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

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
    79653
  • Event Risk Class
    Class 2
  • Event Number
    Z-1386-2018
  • Event Initiated Date
    2018-03-08
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162906
  • 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
    The udi label correctly reads ibr12d-13, however, the inner label incorrectly read ibnt12d-13.
  • Action
    The firm initiated their recall by email on 03/08/2018. The firm requested return of the product.

Device

Device Recall Implant, Ext. Hex, tapered 12o CoAxis
  • Model / Serial
    Lot code: 251J00d2
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US, South Africa, France
  • Product Description
    SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.
  • Manufacturer
    Southern Implants, (Pty.) Ltd.

Manufacturer

Southern Implants, (Pty.) Ltd.
  • Manufacturer Address
    Southern Implants, (Pty.) Ltd., One Albert Road, Irene, Gauteng South Africa
  • Manufacturer Parent Company (2017)
    Southern Implants (Pty) Ltd
  • Source
    USFDA