Recall Z-2436-2019 ยท EJL Bur, Dental
Coltene /Whaledent AG
DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
| Date | Jul 19, 2019 |
| Status | Terminated |
| Reason | A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but different length. |
| Root cause | Error in labeling |
| Action | The firm initiated the recall by email on 07/19/2019 requesting that the consignee return any unused product for replacement. |
| Quantity | 20 units of 5 burs/unit |
| Distribution | GA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.