EVac 70 XTRA with Integrated Cable and PROcise EZ View with… recallZ-2105-2015 · ArthroCare Corporation · initiated Jun 2, 2015
Class II Terminated All recalls posted in July 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ArthroCare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2105-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 2, 2015
- Posted by the FDA
- Jul 18, 2015
- Recalling firm
- ArthroCare Corporation
- Quantity
- 733 devices
- Product code
- GEI
- FDA submissions
- K070374, K142999
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Germany, Spain, United Kingdom, Ireland, India, Italy and Singapore.
Product description
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.
Code information (models, lots, serial numbers)
Lot numbers 1093290 and 1091254
Other devices under the same FDA submission
1 device cleared under K070374, K142999 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- COBLATION EICA8872-01Smith & Nephew, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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