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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 Recall
ArthroWand Saber 30 with Integrated Cable wand
see related information
Date Posted August 30, 2009
Recall Status1 Open
Recall Number Z-1900-2009
Recall Event ID 52722
Premarket Notification
510(K) Number
K030551 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - 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, California 94085-3523
Manufacturer Reason
for Recall
Potential Sterility Loss-- Due to wearing or puncture in the Tyvek lid, the product may lose sterility.
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 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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