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.
데이터 추가 비고
Endosseous, root-form implant - Product Code DZE
원인
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.
조치
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.
Worldwide Distribution including USA and countries of Spain, Canada, Australia and South Africa.
제품 설명
"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.