Events

Recall of Device Recall Stryker Orthobiologics Aliquot Syringe Delivery System, 6", Part Number 20900504

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
    63204
  • Event Risk Class
    Class 2
  • Event Number
    Z-1390-2013
  • Event Initiated Date
    2012-11-10
  • Event Date Posted
    2013-05-24
  • 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=115052
  • 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
    Injector, vertebroplasty (does not contain cement) - Product Code OAR
  • Reason
    There have been a few reported cases of the catheter breaking when removing the aliquot catheter from the needle during vertebroplasty procedures. this has been attributed to bending of the catheter during the retraction from the needle. it was determined to be use errors. the correction is limited to a revision of the directions for use.
  • Action
    Stryker sent an Urgent Medical Device Correction letter dated November 10, 2012 to all affected customers. The letter identified the affected product, problem issue, potential hazards and actions to be taken. Customers were instructed to immediately review this notification and the attached IFU. Customers were asked to complete and sign the enclosed Business Reply Form and fax a copy to 1-484-323-8803. For questions contact Stryker Orthobiologics.

Device

Device Recall Stryker Orthobiologics Aliquot Syringe Delivery System, 6", Part Number 20900504
  • Model / Serial
    Manufacturer Part Number 2090-0504, Lot Numbers A1006026 and A1111020
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
  • Product Description
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 || Product Usage: || 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