Recall Z-2436-2019— Coltene /Whaledent AG
Class II · Terminated
Class II FDA medical device recall by Coltene /Whaledent AG, initiated 2019-07-19, terminated 2021-04-30. FDA's recall record names no specific 510(k) clearance for this event. Product: DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F. 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..
- Recalling firm
- Coltene /Whaledent AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-19
- Terminated
- 2021-04-30
- Firm location
- Altstatten Sg, N/A, Switzerland
Product description
DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.