Dental Handpieces Recalled Due to Detachable Screw Component Risk
Coltene Whaledent Inc is recalling SciCan STATIS SL S10001 dental handpieces because the screw connection between the turbine head and push button may loosen and fall off, creating a risk of swallowing or inhaling these parts.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a mechanical defect with a real aspiration and choking hazard. However, no illnesses or injuries have been reported, placing it at High severity per the rubric.
Plain-English summary
Coltene Whaledent Inc is recalling SciCan STATIS SL S10001 dental handpieces (Model S10001). Approximately 3,896 units are affected.
The screw connection between the turbine head and the push button may loosen and fall off during dental treatment. This creates a risk that patients could swallow or inhale loose pieces of the turbine head or push button.
The recalled handpieces were distributed nationwide and to dental practices in Canada, Germany, Indonesia, Ireland, Lebanon, Saudi Arabia, and Turkey. All serial numbers are affected. Dental professionals should discontinue use immediately and contact Coltene Whaledent Inc or the FDA for guidance on replacement or repair.
The recalled product
- Product
- SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001
- Manufacturer
- Coltene Whaledent Inc
- Affected units
- 3,896
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: +ESANS100010 All Serial Numbers
Distribution
Distributed nationwide across the United States.
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