BEUDAMED
    FDA Recall Terminated

    REF 70-0073-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, RETRO, STRAIGHT, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in orthaepedic surgery where a cutting instrument is required.

    Recall: Z-2257-2010 · Initiated January 28, 2010

    Recall

    Recall Number
    Z-2257-2010
    Event Number
    54701
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    January 28, 2010
    Posted
    August 24, 2010
    Terminated
    December 15, 2010
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    REF 70-0073-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, RETRO, STRAIGHT, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in orthaepedic surgery where a cutting instrument is required.

    Reason

    This recall was due to the possibility that multiple products may have a breach in the poly-Tyvek pouch that could potentially compromise the sterility of the contents.

    Action

    Each consignee will be notified of the recall by an Urgent Medical Device Recall Notification letter sent by FedEx or an equivalent method. The letter identified the affected product, explained the reason for recall, and health risk. Consignees were instructed to examine their inventory and segregate the affected product for return. Customers are to complete and return the Reply Form and to notify their customers if the product was further distributed. Consignees are instructed to return any remaining product to ConMed Linvatec. Questions should be directed to the Customer Service department at 800-535-8536.

    Distribution

    Worldwide Distribution -- United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Republic of Korea, Netherlands, Portugal, Serbia, Singapore, Slovenia, El Salvador, Thailand, Taiwan, South Africa, and throughout the U.S.

    Quantity

    35,451 total