Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SOUTHERN IMPLANTS REF IBR12d-13 Recalled by Southern Implants, (Pty.) Ltd. Due to The UDI label correctly reads IBR12d-13, however, the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Southern Implants, (Pty.) Ltd. directly.
Affected Products
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.
Quantity: 49 units
Why Was This Recalled?
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
Where Was This Sold?
US, South Africa, France
About Southern Implants, (Pty.) Ltd.
Southern Implants, (Pty.) Ltd. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report