BEUDAMED
    FDA Recall 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 · Initiated February 26, 2015

    Recall

    Recall Number
    Z-1353-2015
    Event Number
    70609
    Firm
    Orthovita, Inc., dBA Stryker Orthobiologics.
    FEI Number
    1000307073
    Product Code
    LMH
    Status
    Terminated
    Root Cause
    Storage
    Initiated
    February 26, 2015
    Posted
    March 30, 2015
    Terminated
    July 28, 2015
    Address
    45 Great Valley Pkwy, Malvern, PA, 19355-1302

    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.

    Action

    Orthovita, Inc., dBA Stryker Orthobiiologics made phone notifications in February 2015 to all affected customers. Customers were told that the Vitagel they ordered on x date has an internal procedural mandate that says they must deliver in 35 hours and it has now passed that window. As a precaution until we can confirm that Vitagel delivered after shipping for longer is safe for use we are asking that they quarantine the order in question in the event the delivery occurs. For questions regarding this recall call 610-640-1775.

    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