Class II — W&H DENTALWERK BUERMOOS GMBH
| Recalling firm | W&H Dentalwerk Buermoos GmbH |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads 1:1 on the body of the handpiece |
| Product | W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000 |
| Quantity | 160 pieces |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Australia, Philippines, Sweden. |
| Initiated | 2024-01-16 |
| Classified | 2024-02-20 |
| Recall number | Z-1168-2024 |
| 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 — W&H DENTALWERK BUERMOOS GMBH (Z-1168-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93917/
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