BEUDAMED
    FDA Enforcement Class II Terminated

    Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

    Recall: Z-1353-2015 · Reported April 8, 2015

    Enforcement

    Recall Number
    Z-1353-2015
    Event ID
    70609
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthovita, Inc., dBA Stryker Orthobiologics.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 8, 2015
    Initiation Date
    February 26, 2015
    Classification Date
    March 30, 2015
    Termination Date
    July 28, 2015
    Address
    45 Great Valley Pkwy, N/A, Malvern, PA, 19355-1302, United States

    Description

    Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

    Reason

    Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the validated delivery time.

    Code Info

    Product Numbers: 2113-0000, 2113-0202 , 2113-0205; Lot Numbers: A1407061, A1406053, A1410055, A1501033, A1407037, A1412010, A1412076; Expiry Dates: 02/28/2017, 08/31/2016, 03/31/2017, 10/31/2016, 10/31/2016, 01/31/2017, 09/30/2016

    Distribution

    Nationwide Distribution including NY PA WV MI IL MA TX AR KS FL WI CA MO LA VA IA OH and NC.

    Quantity

    274