FDA recall Z-1386-2018

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 for recall

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

Distribution

US, South Africa, France

Key facts

Status

Terminated

Initiation date

2018-03-08

Report date

2018-04-25

Termination date

2019-09-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irene, Gauteng, South Africa

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1386-2018