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U.S. Department of Health and Human Services

Class 2 Device Recall ArthroCare ArthroWands

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 Class 2 Recall
ArthroCare ArthroWands
see related information
Date Posted September 19, 2008
Recall Status1 Open
Recall Number Z-2309-2008
Recall Event ID 48731
Premarket Notification
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, California 94085-3523
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = ARTHROCARE CORP.
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