Z-2105-2015Class II

EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable

Name: Z-2105-2015 EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable
Creator: ArthroCare Corporation
Published: 2015-06-02
License: https://open.fda.gov/license/

ArthroCare Corporation / initiated 2015-06-02 / Terminated / root cause: manufacturing process

FDA source

ArthroCare Corporation began a recall of EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation, resection, and... on 2015-06-02. FDA classified it as Class II and gives the reason as "Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2105-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-02
Posted: 2015-07-18
Terminated: 2016-06-27
Recalling firm: ArthroCare Corporation
Product: 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.
Root cause tag: manufacturing process
FDA 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 in commerce: 733 devices
Distribution: Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Germany, Spain, United Kingdom, Ireland, India, Italy and Singapore.
Product codes and lots: Lot numbers 1093290 and 1091254

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2105-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2105-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-17

Product code GEI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)