Southern Implants, (Pty.) Ltd. recalls SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the uppe…

Recall date

March 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1386-2018

FDA classification

Class II

Brand / firm

Southern Implants, (Pty.) Ltd.

Sold / distributed

US, South Africa, France

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.