Events

Recall of Device Recall Stryker AutoPlex System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Div. of Stryker Corporation.

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
    74582
  • Event Risk Class
    Class 2
  • Event Number
    Z-2536-2016
  • Event Initiated Date
    2016-06-14
  • Event Date Posted
    2016-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147944
  • 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
    Cement, bone, vertebroplasty - Product Code NDN
  • Reason
    The piston head can become separated from the delivery piston, blocking the injection assembly valve resulting in a cement backflow towards the injector handle. potential for delay in surgery if additional cement needs to be prepared for the injection procedure.
  • Action
    On 6/13/2016, URGENT MEDICAL DEVICE RECALL NOTIFICATION notifications were sent to the affected customers via courier and sales representatives via email. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments: Jennifer Olson 269-389-2644 jennifer.olson@stryker.com

Device

Device Recall Stryker AutoPlex System
  • Model / Serial
    Model Number(s): 0607-687-000 0605-887-000 0605-687-000 0605-683-000  0607-687-000  Lot numbers: 16021012, 16027022, 16049012, 16061012, 16092012, 16107012, 16022012, 16028012, 16049022, 16063012, 16098012, 16109012, 16025012, 16028022, 16049032, 16063022, 16100012, 16109022, 16025022, 16033012, 16053012, 16070012, 16104012, 16113022, 16026012, 16041012, 16056012, 16070022, 16104022, 16113032, 16026022, 16048012, 16056022, 16074012, 16105012, 16118012, 16027012, 16048022, 16060012, 16088012, 16106012, 16118022 0605-887-000  Lot numbers: 16041012, 16040012, 16050012, 16057012, 16069012, 16078012, 16104012, 16112012, 16124012 0605-687-000  Lot numbers: 16041012, 16047012, 16111012 0605-683-000  Lot numbers: 16071012
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, France, Netherlands, Spain, Italy, Canada, Israel, Romania, Switzerland, and United Kingdom.
  • Product Description
    Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone cement. || Stryker AutoPlex System kits contain a cement mixer, cement injector, funnel, and an extension tube assembly whereby bone cement powder and liquid monomer are mixed inside a chamber and transferred into a cement injector automatically. The bone cement is then dispensed directly into a fracture site using the cement injector and introducer needle combination.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA