Recall Z-2105-2015 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ArthroCare Corporation
EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obs
| Date | Jul 18, 2015 (initiated Jun 2, 2015) |
| Status | Terminated |
| Reason | Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications. |
| Root cause | Nonconforming Material/Component |
| Action | Smith&Nephew sent an Urgent Notification letter dated June 10, 2015 via mail/courier service with delivery tracking/confirmation to affected customers. A response form is included in the notification letter. A follow up letter will be sent to non-responding consignees. Customers were instructed to complete the acknowledgement form and return via fax or email. |
| Quantity | 733 devices |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Germany, Spain, United Kingdom, Ireland, India, Italy and Singapore. |
| FDA record | Open on fda.gov |