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U.S. Department of Health and Human Services

Class 2 Device Recall ArthroCare ArthroWands

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  Class 2 Device Recall ArthroCare ArthroWands see related information
Date Initiated by Firm April 09, 2008
Date Posted September 19, 2008
Recall Status1 Terminated 3 on February 14, 2011
Recall Number Z-2309-2008
Recall Event ID 48731
510(K)Number K033584  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product ArthroCare ArthroWand Covator with Integrated Cable Wand, Catalog number AC4340-01. The product is a medical device for human use in electrosurgical cutting and coagulation accessories. Product is indicated for resection, ablation and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Code Information Lot numbers C401580-A, C401770-A, C405180-A, C409550-A, C411570-A, C412350-A, C415070-A, C415970-A, C416150-A, C423570-A, C424960-A, C430270-A, C432770-A, and C434670-A
Recalling Firm/
Manufacturer		 ArthroCare Corporation
680 Vaqueros Ave
Sunnyvale CA 94085-3523
For Additional Information Contact
408-736-0224 Ext. 229
Manufacturer Reason
for Recall		 Product is not secure in packaging, and movement may damage the product or render it non-sterile.
FDA Determined
Cause 2		 Packaging
Action Recall initiated April 9, 2008. All consignees were sent a letter of the recalled product on April 9 and May 13, 2008. All non-responding consignees were sent a second letter titled Recall - Covator with Integrated Cable Wand Recall No. 2951580-06/24/08 on June 24, 2008. Contact Bruce Prothro at 408-735-6229 if you have questions.
Quantity in Commerce 3644 units
Distribution Product was distributed to 247 consignees throughout the US and to Australia, Germany, Italy, UK, Austria, Netherlands, Switzerland, Denmark, South Africa, Finland, Singapore, Spain, Russia and Poland.
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 = GEI and Original Applicant = ARTHROCARE CORP.
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