Z-0298-2009

"LOCATOR Abutment for 5.7 Screw-Vent & Compatibles." Zest Anchors, Inc. Product is sold for use with any...

Name: Z-0298-2009 "LOCATOR Abutment for 5.7 Screw-Vent & Compatibles." Zest Anchors, Inc. Product is sold for use with any...
Creator: Zest Anchors Inc
Published: 2008-04-09
License: https://open.fda.gov/license/

Zest Anchors LLC / initiated 2008-04-09 / Terminated / root cause: manufacturing process

FDA source

Zest Anchors Inc began a recall of "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... on 2008-04-09. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0298-2009
Status: Terminated
Initiated: 2008-04-09
Posted: 2008-12-01
Terminated: 2008-12-02
Recalling firm: Zest Anchors LLC
Product: "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.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 996 units
Distribution: Worldwide Distribution including USA and countries of Spain, Canada, Australia and South Africa.
Product codes and lots: 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 code DZE

K994257Class IILocator Implant AnchorZest Anchors, Inc. / cleared 2000-03-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)