Date Initiated by Firm |
September 13, 2013 |
Date Posted |
November 22, 2013 |
Recall Status1 |
Terminated 3 on January 21, 2014 |
Recall Number |
Z-0382-2014 |
Recall Event ID |
66569 |
510(K)Number |
K070905
|
Product Classification |
Abutment, implant, dental, endosseous - Product Code NHA
|
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. |
Code Information |
Lot # 2676021303 |
Recalling Firm/ Manufacturer |
Southern Implants, Inc 5 Holland Ste 209 Irvine CA 92618-2576
|
For Additional Information Contact |
Jaime Picariello 866-903-9272
|
Manufacturer 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).
|
FDA Determined Cause 2 |
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 in Commerce |
197 units |
Distribution |
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Guatemala, Taiwan. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = NHA and Original Applicant = SOUTHERN IMPLANTS, INC.
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