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 | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature |
| Product | Paltop 1.25 Hex Drivers, Short Part Number: 60-70102 |
| Quantity | 3 Hex Driver |
| Distribution | FL, MA, SC, VA |
| Initiated | 2019-02-22 |
| Classified | 2019-03-27 |
| Terminated | 2020-06-19 |
| Recall number | Z-1064-2019 |
| 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-1064-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82374/
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