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 cutting edge of tissue punches may be potentially damaged with small dents and nicks. |
| Product | Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. |
| Quantity | 101 |
| Distribution | Worldwide Distribution -- US, to the state of California; and, the countries of Canada and Germany |
| Initiated | 2018-01-24 |
| Classified | 2018-04-19 |
| Terminated | 2018-07-30 |
| Recall number | Z-1443-2018 |
| 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-1443-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79615/
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