FDA Device recall Z-1386-2018
SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext by Southern Implants, citing the UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1386-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-08 |
| Published | 2018-04-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Southern Implants |
| Distribution | n/a |
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
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
Identifiers
| code_info | Lot code: 251J00d2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1386-2018%22
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