Events

Recall of Device Recall Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat

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

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
    62834
  • Event Risk Class
    Class 2
  • Event Number
    Z-0431-2013
  • Event Initiated Date
    2012-07-26
  • Event Date Posted
    2012-11-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111813
  • 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
    Agent, absorbable hemostatic, collagen based - Product Code LMF
  • Reason
    When preparing plasma using vitaprep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step. firm has since discovered that if blood is present in the luer connection of the vitaprep following the blood draw step, this blood could be displaced to the outside of the syringe when the vitaprep cap is reattached to the syringe. t.
  • Action
    Stryker sent a "MEDICAL DEVICE FIELD CORRECTION" dated July 26, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter included a Business Reply Form for customers to complete and return via fax to 1-484-323-8803. Contact the firm at 1-888-774-8870 for questions regarding this notice.

Device

Device Recall Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat
  • Model / Serial
    Part number 2113-0013, lot numbers T1203002, T1204005, and T1206001.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution-including the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV
  • Product Description
    Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. || Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.
  • Manufacturer
    Stryker Orthobiologics, Inc.

Manufacturer

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