PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLASMA WAND devices are indicated for ablation, res
FDA device recall Z-1833-2015 · posted 2015-06-25 · Terminated
Recall details
- Recalling firm
- ArthroCare Medical Corporation
- Reason for recall
- Potential component failure resulting in inoperability
- Action taken
- 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
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 2,355 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2015-05-15
- Date posted
- 2015-06-25
- 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 |