Device product
SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.
Z-1386-2018
Product summary
- Event
- Event 79653
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49 units
- Official record key
device-enforcement:Z-1386-2018
Official wording
Reason: The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
Code information: Lot code: 251J00d2
Distribution pattern: US, South Africa, France
Derived failure modes
-
Unknown
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.