Reported Mar 8, 2023 · Ongoing
SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure,…
Coltene Whaledent Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Coltene Whaledent Inc · 235 Ascot Pkwy · Cuyahoga Falls, OH · 44223-3701
Is this the product you have?
- 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 NumberS10001
- Lot codes and dates
- UDI-DI+ESANS100010 All Serial Numbers
- Amount recalled
- 3896 units
Where it was sold
- Nationwide
Why it was recalled
Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button
This product could cause temporary or reversible health problems — stop using it.
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