FDAFDA · Food and drugs·Recall number Z-0382-2014
Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
Published December 4, 2013 · Recall initiated: September 13, 2013
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
Southern Implants is recalling the Tri-Nex healing abutment because the package was incorrectly labeled and packaged as the Tri-Nex healing abutment, 05.0 mm x 5 mm height (HA-L-50-5). The package contains the Tri-Nex healing abutment 05.0 mm x 6.0 mm Flare x 5 mm Height (HA-L-50W-5).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Southern Implants, Inc
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Canada, Guatemala, Taiwan.
- Lot
- Lot # 2676021303
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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