W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
FDA device recall Z-1168-2024 · posted 2024-02-20 · Open, Classified
Recall details
- Recalling firm
- W&H DENTALWERK BUERMOOS GMBH
- Reason for recall
- 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
- Action taken
- W&H Dentalwerk Burmoos GmbH issued Urgent Medical Device Voluntary Recall Letter on 12/16/23 to Distributors and End Users via email. Letter states reason for recall, health risk and action to take: This recall is carried out to the user level. Please return product to W&H Impex Inc. for disposal within two (2) months after receipt of this notification. Address for removal: W&H Impex Inc. Attn. Mona Miron Regulatory Affairs, Technical Service Manager 6490 Hawthorne Dr, Windsor, ON t +1 800 265 6277 The affected products will be exchanged and replaced by W&H Dentalwerk Brmoos GmbH. Instructions for acknowledgement: Please send back the included return response card. CONTACT INFORMATION: Mona Miron Regulatory Affairs Technical Service Manager W&H Impex Inc 6490 Hawthorne Dr, Windsor, ON t +1 800 265 6277 mona.miron@wh.com
- Root cause
- Labeling False and Misleading
- Status
- Open, Classified
- Product code
- KMW
- Quantity affected
- 160 pieces
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Australia, Philippines, Sweden.
- Date initiated
- 2024-01-16
- Date posted
- 2024-02-20
- Location
- BUERMOOS, Austria
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGICAL HANDPIECES, MIKRO SAW HANDPIECES (K080939) | W&H Dentalwerk Buermoos GmbH | 2008-07-29 |