Z-1386-2018 Class II Terminated
FDA device recall Z-1386-2018 was initiated by Southern Implants, (Pty.) Ltd. on March 8, 2018 and is designated Class II. Reason for recall: The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13. The recall status is terminated (terminated September 26, 2019). Affected quantity: 49 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 25, 2018
- Initiation Date
- March 8, 2018
- Termination Date
- September 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 units
Product 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 for Recall
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
Distribution Pattern
US, South Africa, France
Code Information
Lot code: 251J00d2