ArthroCare ArthroWand Covator with Integrated Cable Wand, Catalog number AC4340-01. The product is a medical device for
FDA device recall Z-2309-2008 · posted 2008-09-19 · Terminated
Recall details
- Recalling firm
- ArthroCare Corporation
- Reason for recall
- Product is not secure in packaging, and movement may damage the product or render it non-sterile.
- Action taken
- 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
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 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
- Date initiated
- 2008-04-09
- Date posted
- 2008-09-19
- Date terminated
- 2011-02-14
- Location
- Sunnyvale, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTHROCARE ARTHROWANDS (K033584) | Arthrocare Corp. | 2003-11-28 |