W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000

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

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 [email protected]