FDA Recall
Terminated
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.
Recall: Z-1386-2018
·
Initiated March 8, 2018
Recall
- Recall Number
- Z-1386-2018
- Event Number
- 79653
- Firm
- Southern Implants, (Pty.) Ltd. One Albert Road Irene, Gauteng South Africa
- FEI Number
- 3003394627
- Product Code
- NHA
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- March 8, 2018
- Terminated
- September 26, 2019
Description
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.
Reason
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
Action
The firm initiated their recall by email on 03/08/2018. The firm requested return of the product.
Distribution
US, South Africa, France
Quantity
49 units