SOUTHERN IMPLANTS REF IBR12d-13 — Class II medical device recall Z-1386-2018
Terminated recall by Southern Implants, (Pty.) Ltd., reported 2018-04-25. The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
| Recall number | Z-1386-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Southern Implants, (Pty.) Ltd., Irene, Gauteng, South Africa |
| Recall initiated | 2018-03-08 |
| Classified | 2018-04-16 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2019-09-26 |
| Countries outside the US | FR, ZA |
| Quantity | 49 units |
| Reason classes | labeling |
| Lot numbers | 251J00D2 |
| Model numbers | IBR12D-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.
Reason for recall
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1386-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.