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U.S. Department of Health and Human Services

Class 3 Device Recall "LOCATOR Abutment for 5.7 ScrewVent Compatibles"

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  Class 3 Device Recall "LOCATOR Abutment for 5.7 ScrewVent Compatibles" see related information
Date Initiated by Firm April 09, 2008
Date Posted December 01, 2008
Recall Status1 Terminated 3 on December 02, 2008
Recall Number Z-0298-2009
Recall Event ID 48645
510(K)Number K994257  
Product Classification Endosseous, root-form implant - Product Code DZE
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.
Code Information Product Codes: 8190 (1.0 mm), 8191 (2.0 mm), 8192 (3.0mm), 8193 (4.0mm), 8194 (5.0 mm) and 8195 (6.0mm).
Recalling Firm/
Manufacturer		 Zest Anchors Inc
2061 Wineridge Pl
Escondido CA 92029-1947
For Additional Information Contact
760-743-7744
Manufacturer 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
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = ZEST ANCHORS, INC.
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