Recall Z-1168-2024 ยท KMW Handpiece, Rotary Bone Cutting
W&H DENTALWERK BUERMOOS GMBH
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
| Date | Feb 20, 2024 (initiated Jan 16, 2024) |
| Status | Open, Classified |
| 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 |
| Root cause | Labeling False and Misleading |
| Action | 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 |
| Quantity | 160 pieces |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Australia, Philippines, Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES W&H Dentalwerk Buermoos GmbH, Jul 29, 2008 |