Events

Recall of "LOCATOR Abutment for 5.7 ScrewVent Compatibles"

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zest Anchors Inc.

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
    48645
  • Event Risk Class
    Class 3
  • Event Number
    Z-0298-2009
  • Event Initiated Date
    2008-04-09
  • Event Date Posted
    2008-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71791
  • 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
    Endosseous, root-form implant - Product Code DZE
  • Reason
    The recall was initiated after the firm discovered through a customer complaint that the locator abutments for 5.7 screw-vent & compatibles do not fit properly in all sizes of the zimmer dental 5.7mm diameter tapered screw-vent implants (tsv6b8, tsv6b10, tsv6b11, tsv6b13, tsv6b16, tsv6h8, tsv6h10, tsv6h11, tsv6h13 and tsv6h16). the locator abutment bottoms out in the pilot hole of these implants c.
  • Action
    The recall notification letter (Recall Notice) was sent to consignees on April 23,2008. The letter includes the following information on how to handle the recall. It is very important that you determine the use of the Locator Abutment(s) as follows, mark the appropriate box, ,and return this letter to Zest Anchors, Inc. in the stamped, self-addressed envelope: 1. The Locator Abutment(s) listed above WERE NOT used on any Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implants. THE FIT IS CORRECT AND NO ACTION IS NECESSARY. 2. The Locator Abutment(s) listed above WERE used on a Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implant. PLEASE CONTACT OUR DENTAL OFFICE TO ARRANGE THE R PLACEMENT OF THE ABUTMENT WITH A NEWLY DESIGNED LOCATOR ABUTMENT. and 3. We have current STOCK of the Locator Abutment(s) listed above with planned use for a Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implant. PLEASE CONTACT OUR DENTAL OFFICE TO ARRANGE THE REPLACEMENT OF THE ABUTMENT WITH A NEWLY DESIGNED LOCATOR ABUTMENT. For questions or additional information, contact Zest Anchors, Inc. at 800-262-2310 or 760-743-7744.

Device

"LOCATOR Abutment for 5.7 ScrewVent Compatibles"
  • Model / Serial
    Product Codes: 8190 (1.0 mm), 8191 (2.0 mm), 8192 (3.0mm), 8193 (4.0mm), 8194 (5.0 mm) and 8195 (6.0mm).
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution including USA and countries of Spain, Canada, Australia and South Africa.
  • Product Description
    "LOCATOR Abutment for 5.7 Screw-Vent & Compatibles." Zest Anchors, Inc. Product is sold for use with any Zimmer Dental 5.7 mm diameter Tapered Screw-Vent Implant. || The product is used with supra-gingival, universal hinge, resilient overdenture attachment for endosseous implants.
  • Manufacturer
    Zest Anchors Inc

Manufacturer

Zest Anchors Inc
  • Manufacturer Address
    Zest Anchors Inc, 2061 Wineridge Pl, Escondido CA 92029-1947
  • Manufacturer Parent Company (2017)
    Zest Anchors Inc.
  • Source
    USFDA