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 |
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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 = KOG
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