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

Recall date

January 16, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1168-2024

FDA classification

Class II

Brand / firm

W&H DENTALWERK BUERMOOS GMBH

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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