Class II — Coltene Whaledent Inc
| 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 | The products are labeled with an incorrect product number. |
| Product | Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone. |
| Quantity | 11 |
| Distribution | The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada |
| Initiated | 2018-04-13 |
| Classified | 2018-05-15 |
| Terminated | 2019-04-08 |
| Recall number | Z-1883-2018 |
| 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 — Coltene Whaledent Inc (Z-1883-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79994/
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