Recall Z-1386-2018 ยท NHA Abutment, Implant, Dental, Endosseous
Southern Implants, (Pty.) Ltd.
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.
| Date | Mar 8, 2018 |
| Status | Terminated |
| Reason | The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13. |
| Root cause | Process control |
| Action | The firm initiated their recall by email on 03/08/2018. The firm requested return of the product. |
| Quantity | 49 units |
| Distribution | US, South Africa, France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163634 | External Hex Implants Southern Implants (Pty), Ltd., Nov 6, 2017 |