Recall Z-0298-2009 ยท DZE Implant, Endosseous, Root-Form
Zest Anchors Inc
"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.
| Date | Dec 1, 2008 (initiated Apr 9, 2008) |
| Status | Terminated |
| 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 |
| 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 Den |
| Quantity | 996 units |
| Distribution | Worldwide Distribution including USA and countries of Spain, Canada, Australia and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994257 | LOCATOR IMPLANT ANCHOR Zest Anchors, Inc., Mar 17, 2000 |