Events

Recall of Legacy(TM) 3 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
    78350
  • Event Risk Class
    Class 2
  • Event Number
    Z-0185-2018
  • Event Initiated Date
    2017-10-10
  • 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=159290
  • 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
    One reported complaint and discovered that the outer vial was out of round and undersized. therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. as a result, the cap could possibly not be screwed on properly and the sterilization compromised.
  • Action
    The firm, Implant Direct Sybron Manufacturing, LLC, sent an "URGENT: Safety Alert/Advisory Notice" letter to its distributors/customers on 10/10/2017. Distributors were instructed as follows: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form within 48 hours. 3. If you are an authorized Implant Direct Sybron Manufacturing distributor, we request that you identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of this notification in order to provide the customers with replacement product." Enclosed within this notification, you will find a padded return envelope with replacement product. Please return affected product in the padded envelope. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425. Customers were instructed as follows: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form within 48 hours. Please share this information with your staff and retain this notification as part of your documentation. Enclosed within this notification, you will find a padded return envelope with replacement product. Please return affected product in the padded envelope. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425."

Device

Legacy(TM) 3 Implant
  • Model / Serial
    Lot Number: 79607
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: US (nationwide) including Puerto Rico and country of Japan.
  • Product Description
    ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 || This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment 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