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U.S. Department of Health and Human Services

Class 2 Device Recall SciCan Dental Handpieces

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  Class 2 Device Recall SciCan Dental Handpieces see related information
Date Initiated by Firm January 20, 2023
Date Posted March 02, 2023
Recall Status1 Open3, Classified
Recall Number Z-1208-2023
Recall Event ID 91601
510(K)Number K071891  
Product Classification Handpiece, air-powered, dental - Product Code EFB
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
Code Information UDI-DI: +ESANS100010 All Serial Numbers
Recalling Firm/
Manufacturer		 Coltene Whaledent Inc
235 Ascot Pkwy
Cuyahoga Falls OH 44223-3701
For Additional Information Contact SAME
330-916-8858
Manufacturer 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 Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = EFB and Original Applicant = SCICAN LTD.
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