FDA Medical Device Recalls (openFDA)
Thommen Medical AG: Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and screwed in manually or mechanically.
- Recall number
- Z-1390-2019
- Recalling firm
- Thommen Medical AG
- Product
- Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and screwed in manually or mechanically.
- Status
- Terminated
- Initiated
- 2019-04-03
- Posted
- not on file
- Terminated
- 2019-08-12
- Reason
- Dental adaptor does not conform to specifications. The dental coupling of the adapter can become deformed when being inserted into the implant may make it difficult to remove the adapter from its counterpart (e.g. the handpiece).
- Root cause
- Under Investigation by firm
- Action
- Thommen Medical AG notified the account on 3/27/19 via email asked distributors to put any adapters in their stock in quarantine. Furthermore recall all adapters shipped to their customers. All recovered adapters to be sent back to Thommen Medical AG, who will supply them with new adapters which conform to the specifications.
- Quantity
- 15 US
- Distribution
- US Nationwide distribution in the state of OH.
- Lot, serial or model codes
- Lot number:17415 UDI: 07640182640705
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NDP
- Firm FEI
- 3003184527
- Firm city
- Bettlach
- 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