Z-2436-2019 Class II Terminated
FDA device recall Z-2436-2019 was initiated by Coltene /Whaledent AG on July 19, 2019 and is designated Class II. 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. The recall status is terminated (terminated April 30, 2021). Affected quantity: 20 units of 5 burs/unit.
Recall Details
- Product Type
- Devices
- Report Date
- September 11, 2019
- Initiation Date
- July 19, 2019
- Termination Date
- April 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units of 5 burs/unit
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.
Distribution Pattern
GA
Code Information
Lot/Batch Number J22952