Z-2436-2019Class II

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

Name: Z-2436-2019 DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
Creator: Coltene /Whaledent AG
Published: 2019-07-19
License: https://open.fda.gov/license/

Coltene /Whaledent AG / initiated 2019-07-19 / Terminated / root cause: labeling and UDI

FDA source

Coltene /Whaledent AG began a recall of DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F on 2019-07-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2436-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-19
Posted: 2019-09-04
Terminated: 2021-04-30
Recalling firm: Coltene /Whaledent AG
Product: DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
Product code: EJL Bur, Dental
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm initiated the recall by email on 07/19/2019 requesting that the consignee return any unused product for replacement.
Quantity in commerce: 20 units of 5 burs/unit
Distribution: GA
Product codes and lots: Lot/Batch Number J22952

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2436-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2436-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-08-30

Product code EJL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)