Events

Recall of Device Recall Vitagel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Orthovita, Inc., dBA Stryker Orthobiologics..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70609
  • Event Risk Class
    Class 2
  • Event Number
    Z-1353-2015
  • Event Initiated Date
    2015-02-26
  • Event Date Posted
    2015-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134154
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implant, dermal, for aesthetic use - Product Code LMH
  • 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.

Device

Device Recall Vitagel
  • Model / Serial
    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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including NY PA WV MI IL MA TX AR KS FL WI CA MO LA VA IA OH and NC.
  • Product 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.
  • Manufacturer
    Orthovita, Inc., dBA Stryker Orthobiologics.

Manufacturer

Orthovita, Inc., dBA Stryker Orthobiologics.
  • Manufacturer Address
    Orthovita, Inc., dBA Stryker Orthobiologics., 45 Great Valley Pkwy, Malvern PA 19355-1302
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA