Class II — Coltene /Whaledent AG
| Recalling firm | Coltene/Whaledent AG |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but different length. |
| Product | DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F |
| Quantity | 20 units of 5 burs/unit |
| Distribution | GA |
| Initiated | 2019-07-19 |
| Classified | 2019-08-30 |
| Terminated | 2021-04-30 |
| Recall number | Z-2436-2019 |
| 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 — Coltene /Whaledent AG (Z-2436-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83396/
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