Events

Recall of Device Recall LOCATOR Implant Attachment System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zest Anchors 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
    67315
  • Event Risk Class
    Class 2
  • Event Number
    Z-0935-2014
  • Event Initiated Date
    2014-01-16
  • Event Date Posted
    2014-02-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125247
  • 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
    Zest anchors, llc is voluntarily recalling specific lots of locator¿ implant attachment systems because it is currently provided with a label that indicates that the final torque applied to the abutment should be 30 n-cm. it was recently noted by zest that in order to provide an optimal performance by increasing the factor of safety between the failure load of the abutment screw and the recommend.
  • Action
    Zest Anchors, LLC initiated this recall by sending customers recall notification letter on 01/16/2014 via FedEx overnight. The customer notification letter, titled, "IMPORTANT: MEDICAL DEVICE VOLUNTARY RECALL NOTICE", informed customers of the recall, reason for voluntary recall, product information with part numbers and lot numbers, actions to be taken, and contact information. The customer notification letter was accompanied by a response form titled "MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement & Receipt Form".

Device

Device Recall LOCATOR Implant Attachment System
  • Model / Serial
    Part Numbers: 8875-SPI, 8875-SPI-TMS, 8876-SPI, 8876-SPI-TMS, 08877-SPI, 08877-SPI-TMS, 08878-SPI, 08878-SPI-TMS, 08879-SPI, 08880-SPI; Lot Numbers: 11052, 15306, 20665, 21351, 12025,12259, 22440, I0K7X, I0K7Y, 11963,15307,17676,18934, 25294, 25567, I0JQ7, 12258,12941,15000, 19735, 20666, I0K7Z, I0KY7, 12703, 14568, 19832, 22170, I0LCG, 11093, 13364, 14151, 15624, 20043, 25026, 13530, I0LE4, 10055, 14152, 15001, 25027, 10892, 10893.   Since the LOCATOR¿ Implant Attachment System (including the restorative components) is not sold by the Zest Anchors as a sterilized product, it does not have a designated shelf-life.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in Ohio and Switzerland.
  • Product Description
    LOCATOR¿ Implant Attachment System. || The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. || FDA 510(k): K994257, K072878
  • Manufacturer
    Zest Anchors LLC

Manufacturer

Zest Anchors LLC
  • Manufacturer Address
    Zest Anchors LLC, 2061 Wineridge Pl, Escondido CA 92029-1947
  • Source
    USFDA