Class II

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

W&H DENTALWERK BUERMOOS GMBH · January 16, 2024

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

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Australia, Philippines, Sweden.

States Affected

NATIONWIDE

Quantity Affected

160 pieces

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1168-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

W&H DENTALWERK BUERMOOS GMBH Medical Device Recall: W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000 | SafeCheck