| Class 2 Device Recall ArthroWand Saber 30 with Integrated Cable wand |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GEI
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