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U.S. Department of Health and Human Services

Class 2 Device Recall ArthroCare

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  Class 2 Device Recall ArthroCare see related information
Date Initiated by Firm June 07, 2006
Date Posted June 27, 2006
Recall Status1 Terminated 3 on November 21, 2006
Recall Number Z-1187-06
Recall Event ID 35648
510(K)Number K022229  
Product Classification unknown device name - Product Code KOG
Product ArthroCare brand OPUS Smartstitch Magnum Wire Suture Cartridge, Catalog Number: OM-8075;
Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085
Code Information 31144
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.
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