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 | The implants are mislabeled. |
| Product | Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. |
| Quantity | 72 |
| Distribution | US Distribution to the states of : CA, CT, FL, IN, MA, MD, MI, MN, MT, NJ, NV, NY, TX, and VA. |
| Initiated | 2018-05-01 |
| Classified | 2018-06-11 |
| Terminated | 2018-09-14 |
| Recall number | Z-2162-2018 |
| 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-2162-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80112/
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