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.
This recall has been terminated (originally issued April 3, 2019).
- Recall Initiated
- April 3, 2019
- Terminated
- August 12, 2019
- Recall Number
- Z-1390-2019
- Quantity
- 15 US
- Official Source
- View on FDA website ↗
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).
Distribution
US Nationwide distribution in the state of OH.
Lot / Code Info
Lot number:17415 UDI: 07640182640705
Root Cause
Under Investigation by firm
Action Taken
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.