Z-0382-2014 Class II Terminated

Recalled by Southern Implants, Inc — Irvine, CA

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