Adapter for handpiece — Class II medical device recall Z-1390-2019
Terminated recall by Thommen Medical AG, reported 2019-05-29, distributed nationwide. Dental adaptor does not conform to specifications. The dental coupling of the adapter can become deformed when
| Recall number | Z-1390-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thommen Medical AG, Bettlach, N/A, Switzerland |
| Recall initiated | 2019-04-03 |
| Classified | 2019-05-22 |
| Reported by FDA | 2019-05-29 |
| Terminated | 2019-08-12 |
| Distributed | Nationwide (US) |
| Quantity | 15 us |
| UPC / GTIN / UDI-DI | 07640182640705 |
| Lot numbers | 17415 |
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.
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).
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-1390-2019. 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.