Device recall
Z-0382-2014: Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI…
FDA device recall · Class II · Southern Implants, Inc
Key facts
| Recall number (Z-number) | Z-0382-2014 |
|---|---|
| Recall event | 66569 |
| 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… |
| Product code | NHA |
| Recalling firm | Southern Implants, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 21, 2014 |
| 510(k) numbers | K070905 |
| FEI number | 3003845138 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database