Class 2 Device Recall Implant, Ext. Hex, tapered 12o CoAxis

• Date Initiated by Firm: March 08, 2018
• Create Date: April 16, 2018
• Recall Status: Terminated on September 26, 2019
• Recall Number: Z-1386-2018
• Recall Event ID: 79653
• 510(K)Number: K163634
• Product Classification: Abutment, implant, dental, endosseous - Product Code NHA
• 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.
• Code Information: Lot code: 251J00d2
• FEI Number: 3003394627
• Recalling Firm/ Manufacturer: Southern Implants, (Pty.) Ltd.; One Albert Road; Irene, Gauteng South Africa
• Manufacturer Reason for Recall: The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
• FDA Determined Cause: Process control
• Action: The firm initiated their recall by email on 03/08/2018. The firm requested return of the product.
• Quantity in Commerce: 49 units
• Distribution: US, South Africa, France
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NHA