Tri-Nex Healing Abutment — Class II medical device recall Z-0382-2014
Terminated recall by Southern Implants, Inc, reported 2013-12-04, distributed nationwide. Southern Implants is recalling the Tri-Nex healing abutment because the package was incorrectly labeled and pa
| Recall number | Z-0382-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Southern Implants, Inc, Irvine, CA, United States |
| Recall initiated | 2013-09-13 |
| Classified | 2013-11-22 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2014-01-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GT, TW |
| Quantity | 197 units |
| Reason classes | labeling |
| Lot numbers | 2676021303 |
| Model numbers | HA-L-50-5 |
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 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0382-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.