Class II — Southern Implants, (Pty.) Ltd.
| Recalling firm | SOUTHERN IMPLANTS (PTY) LTD |
|---|---|
| Registered facility | SOUTHERN IMPLANTS (PTY) LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13. |
| 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. |
| Quantity | 49 units |
| Distribution | US, South Africa, France |
| Initiated | 2018-03-08 |
| Classified | 2018-04-16 |
| Terminated | 2019-09-26 |
| Recall number | Z-1386-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Southern Implants, (Pty.) Ltd. (Z-1386-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79653/
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