Events

Recall of Device Recall SwishPlus Implant

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
    79396
  • Event Risk Class
    Class 2
  • Event Number
    Z-1168-2018
  • Event Initiated Date
    2018-01-19
  • 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=162207
  • 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 extender that is packaged with the swishtapered" and swishplus" implant may have been packaged in the incorrect position (upside down in the plastic retainer).
  • Action
    Customers were sent Urgent: Safety Alert/Advisory Notice letters around 01/19/2018. The Notice identified the affected device and the reason for the correction. Instructions for both distributors and doctors include to review inventory for affected product, complete and return the Acknowledgement form within 48 hours of receipt of the letter, follow the included instructions to correct the affected product, and distributors are to notify those customers that may have been shipped the affected product lot and inform them of the issue. Questions should be directed to Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.

Device

Device Recall SwishPlus Implant
  • Model / Serial
    Part No. (Lot No.): 924108 (97347), 924112 (64927, 93563, 98662), 924116 (70543), 924806 (99749), 924810W (93934), 924812W (94204), and 924814 (103199).
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.
  • Product Description
    SwishPlus Implant || Intended for use in support for fixed bridgework.
  • 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