FDA Medical Device Recalls (openFDA)
Coltene /Whaledent AG: DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
- Recall number
- Z-2436-2019
- Recalling firm
- Coltene /Whaledent AG
- Product
- DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
- Status
- Terminated
- Initiated
- 2019-07-19
- Posted
- not on file
- Terminated
- 2021-04-30
- 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.
- 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
- 20 units of 5 burs/unit
- Distribution
- GA
- Lot, serial or model codes
- Lot/Batch Number J22952
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EJL
- Firm FEI
- 3002806620
- Firm city
- Altstatten Sg
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28