Recall Z-2436-2019

Coltene /Whaledent AG · initiated July 19, 2019

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F

Codes / lots: Lot/Batch Number J22952

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.

FDA-determined cause: Error in labeling

Action taken

The firm initiated the recall by email on 07/19/2019 requesting that the consignee return any unused product for replacement.

Details

Recall number
Z-2436-2019
Initiated
July 19, 2019
Terminated
April 30, 2021
Product code
EJL – Bur, Dental
Quantity
20 units of 5 burs/unit
Distribution
GA
Recalling firm
Coltene /Whaledent AG, Altstatten Sg

Official FDA recall record