Z-0382-2014 Class II Terminated
FDA device recall Z-0382-2014 was initiated by Southern Implants, Inc on September 13, 2013 and is designated Class II. Reason for recall: 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 co… The recall status is terminated (terminated January 21, 2014). Affected quantity: 197 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2013
- Initiation Date
- September 13, 2013
- Termination Date
- January 21, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 197 units
Product Description
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.
Reason for Recall
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).
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Guatemala, Taiwan.
Code Information
Lot # 2676021303