ArthroCare ArthroWand Covator with Integrated Cable Wand, Catalog number AC4340-01. The product is a medical device for human use in electrosurgical cutting and coagulation accessories. Product is indicated for resection, ablation and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
FDA Recall Z-2309-2008 · Posted 2008-09-19
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Recalling FirmArthroCare Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2008-04-09
Date Terminated2011-02-14
Product Quantity3644 units
Reason for Recall
Product is not secure in packaging, and movement may damage the product or render it non-sterile.
Firm Action
Recall initiated April 9, 2008. All consignees were sent a letter of the recalled product on April 9 and May 13, 2008. All non-responding consignees were sent a second letter titled Recall - Covator with Integrated Cable Wand Recall No. 2951580-06/24/08 on June 24, 2008.
Contact Bruce Prothro at 408-735-6229 if you have questions.
Root Cause
Packaging
Distribution Pattern
Product was distributed to 247 consignees throughout the US and to Australia, Germany, Italy, UK, Austria, Netherlands, Switzerland, Denmark, South Africa, Finland, Singapore, Spain, Russia and Poland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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