Events

Recall of Device Recall SwishTapered 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
    76111
  • Event Risk Class
    Class 2
  • Event Number
    Z-1112-2017
  • Event Initiated Date
    2016-12-12
  • Event Date Posted
    2017-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152174
  • 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
    The extender product code (9037-03) that is packaged with the swishtapered (part number 933308; lot number 73241) implant was packaged in the incorrect position. this discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.
  • Action
    Customer notification letters were sent on 12/12/16. Customers were requested to review inventory for the affected product. Complete and return the Acknowledgement and Recall Return Form within 48 hours. If customers are an authorized distributor the firm requests that they identify those customers that may have been shipped the affected product lot and contact those customers to inform them of the issue within 48 hours of receipt of the notification in order to provide the customers with replacement product. If customers have any of the affected product the firm will send a replacement part. Any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.

Device

Device Recall SwishTapered Implant
  • Model / Serial
    933308 Lot # 73241
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; Netherlands.
  • Product Description
    SwishTapered Implant
  • 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