Device product
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.
Z-0382-2014
Product summary
- Event
- Event 66569
- Status
- Terminated
- Classification
- Class II
- Quantity
- 197 units
- Official record key
device-enforcement:Z-0382-2014
Official wording
Reason: 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).
Code information: Lot # 2676021303
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Canada, Guatemala, Taiwan.
Derived failure modes
-
Labeling or packaging
incorrectly labeled