Class II — Thommen Medical AG
| Recalling firm | THOMMEN MEDICAL, AG |
|---|---|
| Registered facility | THOMMEN MEDICAL, AG (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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). |
| 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. |
| Quantity | 15 US |
| Distribution | US Nationwide distribution in the state of OH. |
| Initiated | 2019-04-03 |
| Classified | 2019-05-22 |
| Terminated | 2019-08-12 |
| Recall number | Z-1390-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Thommen Medical AG (Z-1390-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82675/
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