Southern Implants, (Pty.) Ltd.: Medical Device Recall in 2018 - (Recall #: Z-1386-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 8, 2018

Date Posted: April 25, 2018

Recall Number: Z-1386-2018

Event ID: 79653

Reason for Recall:

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

Status: Terminated

Product Quantity: 49 units

Code Information:

Lot code: 251J00d2

Distribution Pattern:

US, South Africa, France

Voluntary or Mandated:

Voluntary: Firm initiated