Reported Apr 25, 2018 · Terminated
SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the…
Southern Implants, (Pty.) Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Southern Implants, (Pty.) Ltd. · One Albert Road · Irene, Gauteng · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Lot code251J00d2
- Amount recalled
- 49 units
Why it was recalled
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
This product could cause temporary or reversible health problems — stop using it.
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