Events

Recall of SCORPIO NRG KNEE SYSTEM

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

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
    53588
  • Event Risk Class
    Class 2
  • Event Number
    Z-0470-2010
  • Event Initiated Date
    2009-10-02
  • Event Date Posted
    2009-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85924
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barrier system.
  • Action
    An "Urgent Product Recall" letter was sent on October 2, 2009 by Federal Express to Stryker branches and Hospital Risk Management Departments in the United States as well as foreign consignees. The letter described the issue, potential hazard and actions for affected accounts. Consignees were instructed to examine their inventory and return recalled product as instructed in the notification letter to Stryker Orthopaedics. In addition, consignees were instructed to reconcile affected product by completing the attached Product Accountability form (with spreadsheet) and faxing to 1-201-831-6069. Direct questions to Stryker Orthopaedics by calling 1-201-972-2100.

Device

SCORPIO NRG KNEE SYSTEM
  • Model / Serial
    Catalog number 80-4405L, Lot codes: MHJ1HW and MHJ4RV and Catalog number 80-4405R, Lot codes: MHE4E0 and MHJ4RW.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States (MA, NJ, IN, MI, CA and PA), Hong Kong, Germany, Netherlands, Japan, Korea, Switzerland, Malaysia, and the United Kingdom.
  • Product Description
    Scorpio NRG Cruciate Retaining Femoral, Left/Right # 5; || Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. || The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA