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 | Ongoing |
| Reason | The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant. |
| Product | impression coping, repositionable, short, screw-retained, PF 4.0 |
| Quantity | 20 units |
| Distribution | US Nationwide distribution in the states of OH and KY. |
| Initiated | 2024-01-24 |
| Classified | 2024-03-20 |
| Recall number | Z-1322-2024 |
| 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-1322-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94040/
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