Z-0382-2014Class II

Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to...

Name: Z-0382-2014 Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to...
Creator: Southern Implants, Inc
Published: 2013-09-13
License: https://open.fda.gov/license/

Southern Implants, (Pty.) Ltd. / initiated 2013-09-13 / Terminated / root cause: labeling and UDI

FDA source

Southern Implants, Inc began a recall of 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... on 2013-09-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0382-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-13
Posted: 2013-11-22
Terminated: 2014-01-21
Recalling firm: Southern Implants, (Pty.) Ltd.
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.
Product code: NHA Abutment, Implant, Dental, Endosseous
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).
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Southern Implants, Inc. sent an Urgent Product Action letter dated September 11, 2013, to all affected customers. The letter identiied the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out the customer response form and fax/email the completed form to Customer Support at (866) 903-9272 or [email protected]. For questions regarding this recall call 866-903-9272.
Quantity in commerce: 197 units
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada, Guatemala, Taiwan.
Product codes and lots: Lot # 2676021303

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0382-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0382-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-22

Product code NHA

K070905Class IIEndosseous Dental Implant SystemSouthern Implants, Inc. / cleared 2007-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)