Device recall
Z-1386-2018: SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM)…
FDA device recall · Class II · Southern Implants, (Pty.) Ltd.
Key facts
| Recall number (Z-number) | Z-1386-2018 |
|---|---|
| Recall event | 79653 |
| 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. |
| Product code | NHA |
| Recalling firm | Southern Implants, (Pty.) Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 26, 2019 |
| 510(k) numbers | K163634 |
| FEI number | 3003394627 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database