CLASS II Device recall · Reported 4 Dec 2013 · FDA Enforcement Report

Tri-Nex Healing Abutment height recalled by Southern Implants

Southern Implants is recalling Tri-Nex Healing Abutment height, distributed nationwide in the US. The recall was initiated on 13 Sep 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 2676021303

Quantity recalled197 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0382-2014
FDA event ID: 66569
Recalling firm: Southern Implants, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 13 Sep 2013
FDA classified: 22 Nov 2013
Reported: 4 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Dental Devices

Timeline

13 Sep 2013	Recall initiated by company
22 Nov 2013	Classified by FDA	+70 days
4 Dec 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide

Questions about this recall

Is Tri-Nex Healing Abutment height recalled?

Yes. Southern Implants recalled Tri-Nex Healing Abutment height on 13 Sep 2013. The recall is Class II and its status is Terminated. Recall number Z-0382-2014.

Why was it recalled?

Which lots are affected?

Lot # 2676021303

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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