Z-1390-2019 Class II Terminated
FDA device recall Z-1390-2019 was initiated by Thommen Medical AG on April 3, 2019 and is designated Class II. 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 coun… The recall status is terminated (terminated August 12, 2019). Affected quantity: 15 US.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2019
- Initiation Date
- April 3, 2019
- Termination Date
- August 12, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 US
Product Description
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).
Distribution Pattern
US Nationwide distribution in the state of OH.
Code Information
Lot number:17415 UDI: 07640182640705