ArthroWand Saber 30 with Integrated Cable wand, Catalog number AC4330-01, Manufactured by ArthroCare Corporation, Sunnyv
FDA device recall Z-1900-2009 · posted 2009-08-30 · Terminated
Recall details
- Recalling firm
- ArthroCare Corporation
- Reason for recall
- Potential Sterility Loss-- Due to wearing or puncture in the Tyvek lid, the product may lose sterility.
- Action taken
- Firm initiated this recall on August 5, 2008. Consignees were notified via letter asking them to contact consignees and delivered via courier. Distribution discontinued on July 9, 2008.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 23,443 units (includes distribution of previously returned product)
- Distribution
- Worldwide Distribution including USA and countries of Netherlands, Slovak Republick, Ireland, Spain, Switzerland, Singapore, Russian Federatin, Greece, Japan, Saudi Arabia, India, Slovenia, Israel, So
- Date initiated
- 2008-08-05
- Date posted
- 2009-08-30
- Date terminated
- 2011-06-14
- Location
- Sunnyvale, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE PATIENT CABLE; FOOT CONTROL; POWER CORD; WANDS (K030551) | Arthrocare Corp. | 2003-03-07 |