SciCan STATIS SL S10001 Dental Handpieces-Intended for recall
SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing…
Why was SciCan STATIS SL S10001 Dental Handpieces-Intended for 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: +ESANS100010 All Serial Numbers
- Product
- SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing…
- Recalling firm
- Coltene Whaledent Inc
- Quantity
- 3896 units
- Distribution
- Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey
- Recall date
- March 8, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)