medical Class II Updated 2018-04-25

Southern Implants, (Pty.) Ltd. recalls SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered

Recalled 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.


Hazard / Issue

The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.

Issued by

FDA

Distribution: US, South Africa, France
Lot/Code Info: Lot code: 251J00d2
View official government recall

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