FDA recall Z-2436-2019

Coltene /Whaledent AG · Class II · device

Product

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

Key facts

Status: Terminated
Initiation date: 2019-07-19
Report date: 2019-09-11
Termination date: 2021-04-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Altstatten Sg, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2436-2019