Recall Record

Altstatten Sg, N/A, Switzerland

Coltene /Whaledent AG recalls

1 recall recorded since 2018, most recently on 19 July 2019. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0

Terminated Class II Medical devices

Recall started
19 July 2019
Terminated
30 April 2021
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.
Distribution
GA
Initiated
Voluntary: Firm initiated
Recall number
Z-2436-2019

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.