Recall Z-1386-2018— Southern Implants, (Pty.) Ltd.
Class II · Terminated
Class II FDA medical device recall by Southern Implants, (Pty.) Ltd., initiated 2018-03-08, terminated 2019-09-26. It names one FDA 510(k) clearance: K163634. 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: The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13..
- Recalling firm
- Southern Implants, (Pty.) Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-08
- Terminated
- 2019-09-26
- Firm location
- Irene, Gauteng, South Africa
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
Data sourced from openFDA. This site is unofficial and independent of the FDA.