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.
- Company
- Arthrocare Corporation
- Recall Initiated
- January 31, 2008
- Posted
- September 16, 2008
- Terminated
- January 8, 2011
- Recall Number
- Z-1657-2008
- Quantity
- 2,129
- Firm Location
- Sunnyvale, CA
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.
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, Singapore, Ireland, Spain, Finland, South Korea, Russia and Vietnam.
Lot / Code Info
Lot Numbers: A603250-A, A609450-A, A610250-A, A615750-A, A616850-A, A627860-A, A627860-B, A604670-A, A615870-A, A620170-A, A623270-A, and A634670-A.
Root Cause
Packaging process control
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.