Class II — Southern Implants, Inc
| Recalling firm | SOUTHERN IMPLANTS (PTY) LTD |
|---|---|
| Registered facility | SOUTHERN IMPLANTS (PTY) LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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). |
| 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. |
| Quantity | 197 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada, Guatemala, Taiwan. |
| Initiated | 2013-09-13 |
| Classified | 2013-11-22 |
| Terminated | 2014-01-21 |
| Recall number | Z-0382-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Southern Implants, Inc (Z-0382-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66569/
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