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 obstruction be reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate.
- Company
- Arthrocare Corporation
- Recall Initiated
- June 2, 2015
- Posted
- July 18, 2015
- Terminated
- June 27, 2016
- Recall Number
- Z-2105-2015
- Quantity
- 733 devices
- Firm Location
- Austin, TX
Reason for Recall
Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.
Distribution
Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Germany, Spain, United Kingdom, Ireland, India, Italy and Singapore.
Lot / Code Info
Lot numbers 1093290 and 1091254
Root Cause
Nonconforming Material/Component
Action Taken
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.
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