FDAMarch 8, 2018device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
What to do
FDA enforcement status: Terminated
Brands named
southern implants ptysouthernsouthern implants
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCSouthern Telecom Expands Recall of Lomi Waxing Kits Due to Risk of Serious Injury or Death from Fire and Burn Hazards; Additional Model and Reported Incidents2026-06-25
- FDAOXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem2026-03-03
- FDAAustralian Greenlip Abalone, Frozen, 9 pieces, Net Wt. 23.5 OZ UPC: 93355330133422025-12-24
- CPSCKnog Recalls Bicycle Lights Due to Fire and Burn Hazards2025-10-30
- FDASJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE2025-10-09
- FDASJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE2025-10-09
- FDAOsstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.2025-08-26
- FDAOsstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.2025-08-26
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