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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
ArthroCare Corporation
Lot Codes / Batch Numbers
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.
Products Sold
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.
ArthroCare Corporation is recalling ArthroCare brand Topaz XL ArthroWand with Integrated Cable Wand, Catalog Number: AC4045-01; Product due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, ME, MD, MA, MN, MO, NV, NJ, NY, NC, ND, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI
Page updated: Jan 10, 2026