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

FDA device recall Z-1208-2023 · posted 2023-03-02 · Open, Classified

Recall details

Recalling firm

Coltene Whaledent Inc

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

Action taken

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.

Root cause

Other

Status

Open, Classified

Product code

EFB

Quantity affected

3896 units

Distribution

Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey

Date initiated

2023-01-20

Date posted

2023-03-02

Location

Cuyahoga Falls, OH

Related 510(k) clearances