Recall Z-0382-2014 ยท NHA Abutment, Implant, Dental, Endosseous
Southern Implants, Inc
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
| Date | Nov 22, 2013 (initiated Sep 13, 2013) |
| 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). |
| Root cause | Labeling design |
| Action | Southern Implants, Inc. sent an Urgent Product Action letter dated September 11, 2013, to all affected customers. The letter identiied the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out the customer response form and fax/email the completed form to Customer Support at (866) 903-9272 or customersupport@keystonedental.com. For questions regarding this recall call 866-903-9272. |
| Quantity | 197 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada, Guatemala, Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070905 | ENDOSSEOUS DENTAL IMPLANT SYSTEM Southern Implants, Inc., May 24, 2007 |