EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indi
FDA device recall Z-2105-2015 · posted 2015-07-18 · Terminated
Recall details
- Recalling firm
- ArthroCare Corporation
- Reason for recall
- Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 733 devices
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Germany, Spain, United Kingdom, Ireland, India, Italy and Singapore.
- Date initiated
- 2015-06-02
- Date posted
- 2015-07-18
- Date terminated
- 2016-06-27
- Location
- Austin, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable (K142999) | ArthroCare Corporation | 2014-11-19 |
| ARTHROCARE ENT PLASMA WAND (K070374) | Arthrocare Corp. | 2007-04-25 |