Date Initiated by Firm |
June 06, 2005 |
Date Posted |
July 07, 2005 |
Recall Status1 |
Terminated 3 on November 03, 2005 |
Recall Number |
Z-0975-05 |
Recall Event ID |
32354 |
510(K)Number |
K020096
|
Product Classification |
Implant, Endosseous, Root-Form - Product Code DZE
|
Product |
RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560 |
Code Information |
Lot Number: 1007 |
Recalling Firm/ Manufacturer |
Straumann Manufacturing Inc 60 Minuteman Rd Andover MA 01810
|
For Additional Information Contact |
Linda Jalbert 978-742-2500 Ext. 2506
|
Manufacturer Reason for Recall |
Basal screw is too short to adequately hold the dental abutment in the implant
|
FDA Determined Cause 2 |
Other |
Action |
Straumann USA initiated the recall by letter dated 6/6/05. Users are requested to return devices and to examine patients with the implanted device. |
Quantity in Commerce |
23 |
Distribution |
AZ, CA, DE, FL, NY, OH, OK, TX |
Total Product Life Cycle |
TPLC Device Report
|
|
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.
|
510(K) Database |
510(K)s with Product Code = DZE and Original Applicant = INSTITUT STRAUMANN AG
|