Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0382-2014·Announced 2013-12-04

Southern Implants Recalls Tri-Nex Healing Abutments Due to Labeling Error

Southern Implants is recalling 197 Tri-Nex healing abutments because the packages were incorrectly labeled and contained the wrong product size.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a minor labeling and packaging error where the wrong product size was included, which fits the criteria for moderate severity without reported injuries.

Plain-English summary

Southern Implants, Inc. is recalling 197 units of the Tri-Nex Healing Abutment, 0.50 mm x 5 mm height (Catalog No. HA-L-50-5). The recall was initiated because the packages were incorrectly labeled and packaged as the 0.50 mm x 5 mm height model, but they actually contained the Tri-Nex Healing Abutment 0.50 mm x 6.0 mm Flare x 5 mm Height (Catalog No. HA-L-50W-5).

The affected product is identified by Lot # 2676021303. 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. The incorrect packaging could lead to the use of the wrong abutment size during dental procedures.

The affected units were distributed nationwide in the United States and internationally to Canada, Guatemala, and Taiwan. Consumers and healthcare providers should check their inventory for this specific lot number and stop using the affected products. They should contact Southern Implants, Inc. for further instructions on how to return or dispose of the recalled items.

The recalled product

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…
Manufacturer: Southern Implants, Inc
Category: Medical Device — Dental Implants
Hazard: mis-labeling
wrong-product
Affected units: 197

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot # 2676021303

Distribution

Distributed nationwide across the United States.

Same manufacturer · Southern Implants, Inc

See all →

Moderate
Southern Implants Recalls Dental Implants Due to Labeling Mismatch
FDA (Devices) · 2015-03-18

Same hazard · mis labeling