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U.S. Department of Health and Human Services

Class 2 Device Recall Topaz XL Integrated Cable Wand

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 Class 2 Device Recall Topaz XL Integrated Cable Wandsee related information
Date Initiated by FirmJanuary 31, 2008
Date PostedSeptember 16, 2008
Recall Status1 Terminated 3 on January 08, 2011
Recall NumberZ-1657-2008
Recall Event ID 46962
510(K)NumberK053567 
Product Classification Electrosurgical generator and accessory - Product Code HRX
ProductArthroCare brand Topaz XL ArthroWand with Integrated Cable Wand, Catalog Number: AC4045-01; Product is manufactured and distributed by ArthroCare Corporation, Sunnyvale, CA - Sterile Surgical Device. Product is indicated for ablation and debridement of tendons in orthopedic procedures.
Code Information Lot Numbers:   A603250-A,  A609450-A,  A610250-A,  A615750-A,  A616850-A,  A627860-A,  A627860-B,  A604670-A,  A615870-A,  A620170-A,  A623270-A, and A634670-A.  
FEI Number 3010813691
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		Devices for which sterility may be compromised as evidenced by punctures in the plastic tray during shipping. The risk to the patient is a potential infection subsequent to the surgical procedure.
FDA Determined
Cause 2		Packaging process control
ActionUrgent Product Recall letters (Dated January 31, 2008) were issued to end users of the device (medical professionals) and direct distributors. The letter instructs users to return any affected products.
Quantity in Commerce2,129
DistributionWorldwide Distribution --- USA including states of AL, AR, AZ, CA, CO FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, ND, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and countries of Sweden, Australia, Germany, Italy, UK, Austria, Saudi Arabia, Belgium, Portugal, UAE, Kuwait, Singapore, Ireland, Spain, Finland, South Korea, Russia and Vietnam.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HRX
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