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 | Ongoing |
| Reason | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. |
| Product | Clinic Pack 100 Pieces FG 57 100057C (100057C) |
| Quantity | 556 |
| Distribution | Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada. |
| Initiated | 2020-10-20 |
| Classified | 2020-11-17 |
| Recall number | Z-0466-2021 |
| 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-0466-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86694/
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