Z-1390-2019Class II

Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 -

Name: Z-1390-2019 Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 -
Creator: Thommen Medical AG
Published: 2019-04-03
License: https://open.fda.gov/license/

Thommen Medical AG / initiated 2019-04-03 / Terminated

FDA source

Thommen Medical AG began a recall of 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... on 2019-04-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1390-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-03
Posted: 2019-05-22
Terminated: 2019-08-12
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.
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: 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).
FDA 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 in commerce: 15 US
Distribution: US Nationwide distribution in the state of OH.
Product codes and lots: Lot number:17415 UDI: 07640182640705

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1390-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1390-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22

Product code NDP

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)