BEUDAMED
    FDA Recall Terminated

    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: Z-1657-2008 · Initiated January 31, 2008

    Recall

    Recall Number
    Z-1657-2008
    Event Number
    46962
    Firm
    ArthroCare Corporation
    FEI Number
    3010813691
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    January 31, 2008
    Posted
    September 16, 2008
    Terminated
    January 8, 2011
    Address
    680 Vaqueros Ave, Sunnyvale, CA, 94085-3523

    Description

    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.

    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.

    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.

    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.

    Quantity

    2,129