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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot code: 251J00d2
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Southern Implants, (Pty.) Ltd.
- Reason for Recall:
- The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Lot code: 251J00d2
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1386-2018