PROcise XP Wand with Integrated Cable REF EICA8872-01 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 by 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.
FDA Recall Z-1833-2015 · Posted 2015-06-25
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Recalling FirmArthroCare Medical Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2015-05-15
Date Terminated2016-06-27
Product Quantity2,355 units
Reason for Recall
Potential component failure resulting in inoperability
Firm Action
Smith & Nephew sent an Urgent Product Recall notification letter dated May 15, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, quarantine immediately and return to the address listed on the inventory Return Certification Form.
Root Cause
Component design/selection
Distribution Pattern
US Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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