Recall Z-0382-2014— Southern Implants, Inc

Name: FDA recall Z-0382-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-13

Class II · Terminated

Class II FDA medical device recall by Southern Implants, Inc, initiated 2013-09-13, terminated 2014-01-21. It names one FDA 510(k) clearance: K070905. 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.. 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)..

Recalling firm: Southern Implants, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-09-13
Terminated: 2014-01-21
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K070905 — ENDOSSEOUS DENTAL IMPLANT SYSTEMSouthern Implants, Inc.·cleared 2007-05-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.