BEUDAMED
    FDA Recall Terminated

    Medtronic brand KyphX HV-R Bone Cement, a polymethyl bone cement consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Number: CO1A; Manufactured by Elmdown LTD, London, England, for Medtronic Spine LLC, Sunnyvale, CA. Product is a medical device used during balloon kyphoplasty to cement structures in fractured vertebral bodies.

    Recall: Z-1624-2011 · Initiated November 10, 2009

    Recall

    Recall Number
    Z-1624-2011
    Event Number
    54384
    Firm
    Medtronic Spine LLC, formerly Kyphon Inc
    FEI Number
    3004904811
    Product Code
    NDN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 10, 2009
    Posted
    March 11, 2011
    Terminated
    March 11, 2011
    Address
    1221 Crossman Ave, Sunnyvale, CA, 94089-1103

    Description

    Medtronic brand KyphX HV-R Bone Cement, a polymethyl bone cement consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Number: CO1A; Manufactured by Elmdown LTD, London, England, for Medtronic Spine LLC, Sunnyvale, CA. Product is a medical device used during balloon kyphoplasty to cement structures in fractured vertebral bodies.

    Reason

    Product may not reach proper viscosity (dough state) and inconsistency or lack of homogeneity during cement preparation and during delivery period.

    Action

    The firm, Medtronic Spine LLC, sent an "URGENT DEVICE RECALL NOTICE" dated November 9, 2009 to the customers. The notice described the product, problem and actions to be taken. The customers were instructed to return the affected lots to Medtronic Spine; to not use any of the affected product that they may have received (Medtronic will replace any affected product in their inventory), the customer should contact their Medtronic Spine sales representative or customer service at [866-959-7466 or for geography] for assistance with replacement product, and complete and return the URGENT DEVICE RECALL NOTICE: Action Required form to Medtronic Spine LLC via fax at (408) 543-6192 or mail to: Medtronic Spine LLC, Attn: Recall Coordinator, 1221 Crossman Avenue, Sunnyvale, CA 94089. If you have any questions about this notification, please do not hesitate to contact Sr. Director, Regulatory Affairs via email: [email protected] or phone at (408) 548-5235.

    Distribution

    USA including states of: AL, AR, AZ, CA, CO, DC, FL, GA, IA, IN, KY, MA, MD, MO, MT, NC, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries including: Argentina, Austria, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Ivory Coast, Jordan, Kuwait, Lebanon, Luxembourg, Lybia, Malaysia, Malta, Mexico, Morocco, Netherlands, New Caledonia, Norway, Panama, Philippines, Poland, Portugal, Puerto Rico, Reunion, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Turkey, United Arab Emirates, United Kingdom and Vietnam.