Z-2309-2008

ArthroCare ArthroWand Covator with Integrated Cable Wand, Catalog number AC4340-01. The product is a medical...

Name: Z-2309-2008 ArthroCare ArthroWand Covator with Integrated Cable Wand, Catalog number AC4340-01. The product is a medical...
Creator: ArthroCare Corporation
Published: 2008-04-09
License: https://open.fda.gov/license/

ArthroCare Corporation / initiated 2008-04-09 / Terminated / root cause: packaging

FDA source

ArthroCare Corporation began a recall of ArthroCare ArthroWand Covator with Integrated Cable Wand, Catalog number AC4340-01. The product is a medical device for human use in electrosurgical cutting... on 2008-04-09. The reason FDA records is "Product is not secure in packaging, and movement may damage the product or render it non-sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2309-2008
Status: Terminated
Initiated: 2008-04-09
Posted: 2008-09-19
Terminated: 2011-02-14
Recalling firm: ArthroCare Corporation
Product: 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Product is not secure in packaging, and movement may damage the product or render it non-sterile.
Root cause tag: packaging
FDA root cause: Packaging
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.
Quantity in commerce: 3644 units
Distribution: 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.
Product codes and lots: Lot numbers C401580-A, C401770-A, C405180-A, C409550-A, C411570-A, C412350-A, C415070-A, C415970-A, C416150-A, C423570-A, C424960-A, C430270-A, C432770-A, and C434670-A

Product code GEI

K033584Class IIArthrocare ArthrowandsArthrocare Corp. / cleared 2003-11-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)