Southern Implants, Inc: Medical Device Recall in 2013 - (Recall #: Z-0382-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 13, 2013

Date Posted: December 4, 2013

Recall Number: Z-0382-2014

Event ID: 66569

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).

Status: Terminated

Product Quantity: 197 units

Code Information:

Lot # 2676021303

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Canada, Guatemala, Taiwan.

Voluntary or Mandated:

Voluntary: Firm initiated