FDA recall Z-1168-2024

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2024-01-16

Report date

2024-02-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

BUERMOOS, N/A, Austria

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1168-2024