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U.S. Department of Health and Human Services

Class 2 Device Recall ArthroWand Saber 30 with Integrated Cable wand

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  Class 2 Device Recall ArthroWand Saber 30 with Integrated Cable wand see related information
Date Initiated by Firm August 05, 2008
Date Posted August 30, 2009
Recall Status1 Terminated 3 on June 14, 2011
Recall Number Z-1900-2009
Recall Event ID 52722
510(K)Number K030551  
Product Classification Electricsurgical cutting and coagulation device - Product Code GEI
Product ArthroWand Saber 30 with Integrated Cable wand, Catalog number AC4330-01, Manufactured by ArthroCare Corporation, Sunnyvale, CA
Code Information Lot numbers 4T011660-A, 4T01670-A, 4T01670-B, 4T02460-A, 4T02670-A, 4T02980-A, 4T02980-B, 4T03160-A, 4T04480-A, 4T04480B, 4T04860-A, 4T04980-A, 4T04980-B, 4T06680-A, 4T06680-B, 4T06770-A, 4T07360-A, 4T07460-A, 4T07880-A, 4T08580-A, 4T09270-A, 4T09370-A, 4T09370-B, 4T09370-C, 4T09380-A, 4T09460-A, 4T09580-A, 4T09880-A, 4T10980-A, 4T12260-A, 4T12680-A, 4T12970-A, 4T13380-A, 4T13960-A, 4T13960-B, 4T14980-A, 4T14980-B, 4T15680-A, 4T16360-A, 4T17670-A, 4T17770-A, 4T18760-A, 4T18760-B, 4T18860-A, 4T19770-A, 4T20260-A, 4T20570-A, 4T20660-A, 4T21050-A, 4T22960-A, 4T22960-B, 4T22970-A, 4T24270-A, 4T24270-B, 4T24960-A, 4T25650-A, 4T26970-A, 4T27160-A, 4T27750-A, 4T28260-A, 4T28260-B, 4T29350-A, 4T30270-A, 4T30370-A, 4T32050-A, 4T32060-A, 4T32770-A, 4T33260-A, 4T34150-A, and 4T34960-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		 Potential Sterility Loss-- Due to wearing or puncture in the Tyvek lid, the product may lose sterility.
FDA Determined
Cause 2		 Package design/selection
Action Firm initiated this recall on August 5, 2008. Consignees were notified via letter asking them to contact consignees and delivered via courier. Distribution discontinued on July 9, 2008.
Quantity in Commerce 23,443 units (includes distribution of previously returned product)
Distribution Worldwide Distribution including USA and countries of Netherlands, Slovak Republick, Ireland, Spain, Switzerland, Singapore, Russian Federatin, Greece, Japan, Saudi Arabia, India, Slovenia, Israel, South Africa, South Korea, Poland, Thailand, Jordan, Belgium, Finland, Portugal, Cyprus, Italy, UAE, Kuwait, China, Bahrain, Denmark, Norway, Sweden, Australia, Germany, Austria, UK, New Zealand, Mexico and Canada.
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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