Events

Recall of Device Recall Legacy 4 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
    79885
  • Event Risk Class
    Class 2
  • Event Number
    Z-1920-2018
  • Event Initiated Date
    2016-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163811
  • 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 vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. the main vial label was correctly labeled.
  • Action
    Letters dated 11/14/2016 were issued via FedEx overnight on 11/15/2016.

Device

Device Recall Legacy 4 Implant
  • Model / Serial
    Lot #71729
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distribution was made to FL, GA, MD, MI, NC, NY, OR, TX, UT and VA. There was no foreign/military/government distribution.
  • Product Description
    ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
  • 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