W & H DentalWerk Recalls S-N1 and S-N2 Foot Controls
W & H DentalWerk is recalling S-N1 and S-N2 foot controls because they may fail to stop the motor, posing a risk of serious patient injury.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the malfunction may lead to a 'serious injury of the patient,' which aligns with the rubric criteria for a score of 4 (Severe) involving significant injury reports or risks.
Plain-English summary
W & H DentalWerk Burmoos GMBH is recalling specific models of foot controls, identified as S-N1 and S-N2. These devices are variable foot controls used with drive units that operate mechanical instruments. The recall covers units distributed nationwide in the United States.
The recall was initiated after postmarket surveillance identified a potential malfunction where the foot control might not switch back to the zero position when the pedal is released. If this error occurs, the motor continues to rotate. The source text notes that if this happens during automatic thread cutting or automatic screwing-in of implants, it may lead to a serious injury of the patient in the worst case.
The recall is classified as Class II by the FDA. Affected units are identified by specific reference numbers and serial number ranges listed in the agency's records. Users of these devices should stop using the affected foot controls and contact the manufacturer for further instructions.
The recalled product
- Product
- Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
- Manufacturer
- W & H DentalWerk Burmoos GMBH - Site 1
Distribution
Distributed nationwide across the United States.
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