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 implant
FDA device recall Z-0382-2014 · posted 2013-11-22 · Terminated
Recall details
- Recalling firm
- Southern Implants, Inc
- 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).
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- NHA
- Quantity affected
- 197 units
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Canada, Guatemala, Taiwan.
- Date initiated
- 2013-09-13
- Date posted
- 2013-11-22
- Date terminated
- 2014-01-21
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOSSEOUS DENTAL IMPLANT SYSTEM (K070905) | Southern Implants, Inc. | 2007-05-24 |