FDA Medical Device Recalls (openFDA)
Coltene Whaledent Inc: 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
- Recall number
- Z-1208-2023
- Recalling firm
- Coltene Whaledent Inc
- 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
- Status
- Open, Classified
- Initiated
- 2023-01-20
- Posted
- 2023-03-02
- Terminated
- not on file
- Reason
- 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
- Root cause
- Other
- Action
- Coltene issued Urgent Medical Device Correction to Distributors. The written notification included the Field Safety Notice issued by the manufacturer and the Correction Notice that was issued on January 20th, 202 via Email. Letter states reason for notification, health risk, and action to take: Warning: When using the STATIS SL turbines with REF 2.000.7300 / S10001, with the lack of care or age-related wear and tear, there is a possibility that the push button on the turbine will come loose and this will increase the risk of swallowing or inhaling part of the turbines head or the push button. Recommended action for users: Please urgently observe the following safety instructions from the instructions for use on handling, care and running behaviour of the turbine to protect your patients. This notice needs to be passed on to all those who need to be aware, both within your own organization and in organizations where the potentially affected devices have been transferred. Please ensure that this information and the associated action are followed for a reasonable period of time to ensure the effectiveness of the action.
- Quantity
- 3896 units
- Distribution
- Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey
- Lot, serial or model codes
- UDI-DI: +ESANS100010 All Serial Numbers
- 510(k) numbers
- ["K071891"]
- PMA numbers
- not on file
- Product code
- EFB
- Firm FEI
- 2416455
- Firm city
- Cuyahoga Falls
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28