Events

Recall of Device Recall Replant Overdenture Abutment

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Implant Direct Sybron Manufacturing, LLC.

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
    75838
  • Event Risk Class
    Class 2
  • Event Number
    Z-0961-2017
  • Event Initiated Date
    2016-11-28
  • Event Date Posted
    2017-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151437
  • 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
    Implant, endosseous, root-form - Product Code DZE
  • Reason
    Consignees received product 6060-62, replant overdenture abutment with the label for 4500-61 godirect screw-retaining top.
  • Action
    On 11/28/16 customers were called and instructed to return the product.

Device

Device Recall Replant Overdenture Abutment
  • Model / Serial
    Lot #75808
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    U.S. distribution to the following; WA. Foreign distribution to the following; Netherlands.
  • Product Description
    GoDirect Screw-Retaining Top || Part Numbers: 4500-61
  • Manufacturer
    Implant Direct Sybron Manufacturing, LLC

Manufacturer

Implant Direct Sybron Manufacturing, LLC
  • Manufacturer Address
    Implant Direct Sybron Manufacturing, LLC, 3050 E Hillcrest Dr, Westlake Village CA 91362-3171
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA