Events

Recall of Device Recall Aliquot Delivery Kit (Syringe and Plunger)

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
    72054
  • Event Risk Class
    Class 2
  • Event Number
    Z-2772-2015
  • Event Initiated Date
    2015-08-20
  • Event Date Posted
    2015-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139677
  • 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
    Dispenser, cement - Product Code KIH
  • Reason
    Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration.
  • Action
    Stryker Sent an Urgent Product Recall letter dated August 20, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by the Customer/User: Our records indicate that you have received the above referenced instruments. It is Stryker Orthobiologics responsibility as the manufacturer to ensure that customers who may have received these affected instruments also receive this important communication. Please assist us in meeting our regulatory obligation by faxing back the attached Product Recall Acknowledgment Form as soon as possible to 215-253-5020. We regret any inconvenience this action may cause you and if you have any questions, please contact Stryker Orthobiologics at 610-640-1775 x 5299.

Device

Device Recall Aliquot Delivery Kit (Syringe and Plunger)
  • Model / Serial
    All lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Denmark, France, Germany, Italy, Malta, Netherlands, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.
  • Product Description
    Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
  • 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