ArthroCare brand Topaz XL ArthroWand with Integrated Cable Wand, Catalog Number: AC4045-01; Product is manufactured and
FDA device recall Z-1657-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- ArthroCare Corporation
- Reason for recall
- Devices for which sterility may be compromised as evidenced by punctures in the plastic tray during shipping. The risk to the patient is a potential infection subsequent to the surgical procedure.
- Action taken
- Urgent Product Recall letters (Dated January 31, 2008) were issued to end users of the device (medical professionals) and direct distributors. The letter instructs users to return any affected products.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 2,129
- Distribution
- Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, ND, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and countries of S
- Date initiated
- 2008-01-31
- Date posted
- 2008-09-16
- Date terminated
- 2011-01-08
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATHROCARE TOPAZ ARTHROWANDS (K053567) | Arthrocare Corp. | 2006-03-06 |