W&H Surgical Handpiece S-12 Recalled for Incorrect Laser Marking
W&H Surgical handpiece S-12 devices were incorrectly laser marked with '1:1' instead of the correct '1:2' during production. 160 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Class II recall with a labeling defect and no reported illnesses or injuries. The incorrect laser marking constitutes a minor labeling error, meeting the criteria for Moderate (Score 2).
Plain-English summary
W&H DENTALWERK BUERMOOS GMBH is recalling the W&H Surgical handpiece S-12 (Model Number 30061000) due to incorrect laser marking during production. The handpieces were marked with '1:1' when they should have been marked with '1:2'.
The laser marking error affects 160 units with serial numbers ranging from 04931 through 05121 (with some serial numbers not included in the range). The UDI-DI for the product is J021300610011.
Affected devices were distributed worldwide, including throughout the United States, Canada, Australia, the Philippines, and Sweden. Dental healthcare providers and facilities that received these units should identify affected handpieces by their serial numbers.
Healthcare providers who have received affected units should contact W&H DENTALWERK BUERMOOS GMBH regarding corrective actions.
The recalled product
- Product
- W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
- Manufacturer
- W&H DENTALWERK BUERMOOS GMBH
- Category
- Medical Device — Surgical/Dental
- Hazard
- Affected units
- 160
Distribution
Distributed nationwide across the United States.
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