Recall Z-1208-2023 ยท EFB Handpiece, Air-Powered, Dental
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
| Date | Mar 2, 2023 (initiated Jan 20, 2023) |
| Status | Open, Classified |
| 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. |
| Quantity | 3896 units |
| Distribution | Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071891 | STATIS DENTAL HANDPIECES Scican , Ltd., Sep 13, 2007 |