Date Initiated by Firm |
June 07, 2006 |
Date Posted |
June 27, 2006 |
Recall Status1 |
Terminated 3 on November 21, 2006 |
Recall Number |
Z-1186-06 |
Recall Event ID |
35648 |
510(K)Number |
K022229
|
Product Classification |
unknown device name - Product Code KOG
|
Product |
ArthroCare brand OPUS Smartstitch Suture Cartridge, Catalog Number: OM-8071; Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085
|
Code Information |
21134 |
Recalling Firm/ Manufacturer |
ArthroCare Corporation 680 Vaqueros Ave Sunnyvale CA 94085-3523
|
Manufacturer Reason for Recall |
Potential loss of product sterility due to breach of pouch seal.
|
FDA Determined Cause 2 |
Packaging process control |
Action |
Notification letters were sent to all customers in the United States on June 7, 2006. All letters were sent via overnight delivery. |
Distribution |
Worldwide |
|
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 = KOG and Original Applicant = OPUS MEDICAL, INC.
|