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ArthroCare ArthroWand Covator with Integrated Cable Wand… recallZ-2309-2008 · ArthroCare Corporation · initiated Apr 9, 2008

Terminated All recalls posted in September 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from ArthroCare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Product is not secure in packaging, and movement may damage the product or render it non-sterile.

FDA root cause category: Packaging

What the company is doing

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.

Recall details

Recall number
Z-2309-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 9, 2008
Posted by the FDA
Sep 19, 2008
Recalling firm
ArthroCare Corporation
Quantity
3644 units
Product code
GEI
FDA submissions
K033584
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 description

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

17 devices cleared under K033584 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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