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

Recall Insight

This FDA Devices action (record #Z-1168-2024) was formally reported on February 28, 2024, with the manufacturer initiating the action on January 16, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. W&h Dentalwerk Buermoos Gmbh is listed as the recalling firm, operating out of BUERMOOS, N/A. Federal records indicate 160 pieces units are affected.

The documented reason for this recall is: 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 data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Canada, Australia, Philippines, Sweden.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.