Z-1208-2023Class II

SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth...

Name: Z-1208-2023 SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth...
Creator: Coltene Whaledent Inc
Published: 2023-01-20
License: https://open.fda.gov/license/

Coltene /Whaledent AG / initiated 2023-01-20 / Open, Classified

FDA source

Coltene Whaledent Inc began a recall of SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth... on 2023-01-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1208-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-01-20
Posted: 2023-03-02
Recalling firm: Coltene /Whaledent AG
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
Product code: EFB Handpiece, Air-Powered, Dental
Reason for recall: 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
FDA 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 in commerce: 3896 units
Distribution: Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey
Product codes and lots: UDI-DI: +ESANS100010 All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1208-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1208-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-03-02

Product code EFB

K071891Class IStatis Dental HandpiecesScican , Ltd. / cleared 2007-09-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)