impression coping — Class II medical device recall Z-1322-2024
Ongoing recall by Thommen Medical AG, reported 2024-03-27, distributed nationwide. The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping
| Recall number | Z-1322-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thommen Medical AG, Bettlach, Switzerland |
| Recall initiated | 2024-01-24 |
| Classified | 2024-03-20 |
| Reported by FDA | 2024-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 20 units |
| UPC / GTIN / UDI-DI | 07640156475463 |
| Lot numbers | 30972 |
Product
impression coping, repositionable, short, screw-retained, PF 4.0
Reason for recall
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1322-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.