Device 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.
Z-1390-2019
Product summary
- Event
- Event 82675
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 US
- Official record key
device-enforcement:Z-1390-2019
Official wording
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).
Code information: Lot number:17415 UDI: 07640182640705
Distribution pattern: US Nationwide distribution in the state of OH.
Derived failure modes
-
Unknown
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).