Recall Z-1390-2019 ยท NDP Accessories, Implant, Dental, Endosseous
Thommen Medical AG
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.
| Date | Apr 3, 2019 |
| 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). |
| 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 | 15 US |
| Distribution | US Nationwide distribution in the state of OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.