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Southern Implants, (Pty.) Ltd. recalls SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper
Recalled April 25, 2018 · FDA recall Z-1386-2018 · Southern Implants, (Pty.)
Hazard
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13. · FDA Class II
Units
49 units
Sold at
US, South Africa, France
Description
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-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.
Manufacturer(s)
Southern Implants, (Pty.) Ltd.
Made in
South Africa
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →