BEUDAMED
    FDA Recall Terminated

    Orthovita(R) Cortoss(TM) Delivery Gun Product Usage: Used for the application of Cortoss(TM) Bone Augmentation Material

    Recall: Z-3188-2011 · Initiated March 31, 2011

    Recall

    Recall Number
    Z-3188-2011
    Event Number
    58478
    Firm
    Orthovita, Inc.
    FEI Number
    1000307073
    Product Code
    KIH
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    March 31, 2011
    Posted
    September 12, 2011
    Terminated
    September 25, 2012
    Address
    45 Great Valley Pkwy, Malvern, PA, 19355-1302

    Description

    Orthovita(R) Cortoss(TM) Delivery Gun Product Usage: Used for the application of Cortoss(TM) Bone Augmentation Material

    Reason

    Recalling firm has discovered through internal testing that the Cortoss(TM) Delivery Gun may abrade its packaging material under certain transportation and handling conditions. This abrasion may cause small holes or tears in the packaging material, which may not be immediately visible to the user. Although t the Cortoss(TM) Delivery Gun is provided in double pouches and there have been no report

    Action

    Orthovita sent an "URGENT FIELD SAFETY NOTICE" letter dated March 31, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to Identify, quarantine and discontinue use of the affected product. The letter included an acknowledgement form to be completed and returned as per instructions.. The letter states that the recalling firm will contact customers to arrange for the return or destruction of any affected product. A pre-paid shipping label is provided for product return. The letter also states that the recalling firm will provide replacement product at no cost. For any questions regarding this notice call 484-323-8860.

    Distribution

    Product was distributed within the US to medical facilities in AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NY, NC, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, and WI. Government accounts include Bethesda Naval Center, 8901 Rockville Pike, Bethesda, MD; Lackland Air Force Base, 2200 Berquist Drive, Suite 1, Lackland AFB, TX; Hunter Holmes McGuire VA Hospital 1201 Broad Rock Blvd., Richmond, VA; Madigan Army Medical Center, Madigan Army Medical Center, Tacoma, WA; Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston, SC; VA Medical Center, 1481 W. 10th St., Indianapolis, IN; VA Hospital of Palo Alto, 3801 Miranda Ave., Palo Alto, CA; VA Loma Linda Healthcare System, 11201 Benton Street, Loma Linda, CA; and VA Medical Center/NY Harbor Healthcare, NY, NY.

    Quantity

    3174