Recall Z-1657-2008 ยท HRX Arthroscope
ArthroCare Corporation
ArthroCare brand Topaz XL ArthroWand with Integrated Cable Wand, Catalog Number: AC4045-01; Product is manufactured and distributed by ArthroCare Corporation, Sunnyvale, CA - Sterile Surgical Device. Product is indicated for ablation and debridement of tendons in orthopedic procedures.
| Date | Sep 16, 2008 (initiated Jan 31, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging process control |
| Action | 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. |
| Quantity | 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 Sweden, Australia, Germany, Italy, UK, Austria, Saudi Arabia, Belgium, Portugal, UAE, Kuwait, Singapo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053567 | ATHROCARE TOPAZ ARTHROWANDS Arthrocare Corp., Mar 6, 2006 |