Z-1322-2024 Class II Ongoing
FDA device recall Z-1322-2024 was initiated by Thommen Medical AG on January 24, 2024 and is designated Class II. Reason for recall: The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant. The recall status is ongoing. Affected quantity: 20 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2024
- Initiation Date
- January 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product Description
impression coping, repositionable, short, screw-retained, PF 4.0
Reason for Recall
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
Distribution Pattern
US Nationwide distribution in the states of OH and KY.
Code Information
Article No. 3.03.079; UDI/DI: 07640156475463; Lot No. 30972.