Events

Recall of Device Recall Implant Direct, INTERACTIVE HEALING COLLAR

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
    78917
  • Event Risk Class
    Class 2
  • Event Number
    Z-0539-2018
  • Event Initiated Date
    2018-01-23
  • 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=160855
  • 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
    Interactive healing collar, lot number 104203, labeled as sterile with distributed prior to being sterilized.
  • Action
    The firm initiated their recall on 01/23/2018 by letter. the recall notices requested the following actions by the distributors: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form with the affected product, if available, 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." The letter disseminated to the physician requested the following actions: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form with the affected product, if available, within 48 hours."

Device

Device Recall Implant Direct, INTERACTIVE HEALING COLLAR
  • Model / Serial
    Lot Number 104203
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    CO, SC, IA, NJ, FL, CA, VA, ID, Netherlands
  • Product Description
    Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
  • 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