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Terminated

ArthroWand Saber 30 with Integrated Cable wand, Catalog number AC4330-01, Manufactured by ArthroCare Corporation, Sunnyvale, CA

FDA Recall Z-1900-2009 · Posted 2009-08-30

Recalling FirmArthroCare Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2008-08-05
Date Terminated2011-06-14
Product Quantity23,443 units (includes distribution of previously returned product)

Reason for Recall

Potential Sterility Loss-- Due to wearing or puncture in the Tyvek lid, the product may lose sterility.

Firm 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.

Root Cause

Package design/selection

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030551ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE PATIENT CABLE; FOOT CONTROL; POWER CORD; WANDSArthrocare Corp. · 2003-03-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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