FDAFDA · Food and drugs·Recall number Z-1386-2018
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.
Published April 25, 2018 · Recall initiated: March 8, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Southern Implants, (Pty.) Ltd.
- Distributor
- US, South Africa, France
- Lot
- Lot code: 251J00d2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- South Africa
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