FDA Enforcement
Class II
Ongoing
impression coping, repositionable, short, screw-retained, PF 4.0
Recall: Z-1322-2024
·
Reported March 27, 2024
Enforcement
- Recall Number
- Z-1322-2024
- Event ID
- 94040
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Thommen Medical AG
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 27, 2024
- Initiation Date
- January 24, 2024
- Classification Date
- March 20, 2024
- Address
- Eschenweg 3, Bettlach, N/A, Switzerland
Description
impression coping, repositionable, short, screw-retained, PF 4.0
Reason
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
Code Info
Article No. 3.03.079; UDI/DI: 07640156475463; Lot No. 30972.
Distribution
US Nationwide distribution in the states of OH and KY.
Quantity
20 units