Recall Z-2309-2008 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ArthroCare Corporation
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.
| Date | Sep 19, 2008 (initiated Apr 9, 2008) |
| Status | Terminated |
| Reason | Product is not secure in packaging, and movement may damage the product or render it non-sterile. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033584 | ARTHROCARE ARTHROWANDS Arthrocare Corp., Nov 28, 2003 |