Class II — Keystone Dental Inc
| Recalling firm | Keystone Dental Inc. |
|---|---|
| Registered facility | Keystone Dental Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Abutments are unable to accept the final abutment screw |
| Product | Multi-Unit Abutment Angled, 17®, 4mm Cuff 4.1/4.5mm TiLobe® Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework. |
| Quantity | 20 units |
| Distribution | US Nationwide Distribution in the states of ND, NJ & MA |
| Initiated | 2017-06-20 |
| Classified | 2018-02-13 |
| Terminated | 2018-04-09 |
| Recall number | Z-0608-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Keystone Dental Inc (Z-0608-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79040/
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