Events

Recall of Device Recall GMRS Proximal Femoral Surgical Protocol

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
    46275
  • Event Risk Class
    Class 2
  • Event Number
    Z-0668-2008
  • Event Initiated Date
    2007-12-18
  • Event Date Posted
    2008-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67097
  • 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
    Femur Prosthesis Surgical Literature - Product Code JDI
  • Reason
    The gmrs proximal femoral surgical protocol states " the gmrs proximal femoral components are fully compatabile with all stryker v40 femoral heads." this statement is incorrect and conflicts with the alumina head label and packaging insert.
  • Action
    Stryker sent Urgent Product Recall notification letters and Product Accountability forms via FedEx on 12/21/2007, return receipt requested. An Urgent Product Recall letter dated 1/7/2008, was sent to surgeons who are GMRS users, advising that the GMRS Proximal femoral components are not compatible with Alumina ceramic heads.

Device

Device Recall GMRS Proximal Femoral Surgical Protocol
  • Model / Serial
    Literature number: LSPK41; 10 surgical protocols per package.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA, Canada, Mexico, China, Australia, Hong Kong, Singapore, Sweden, Germany, Brussels, the Netherlands, Italy, Poland, Dubai, United Kingdom, Spain, and South Africa.
  • Product Description
    Stryker GMRS Proximal Femoral Surgical Protocol; || Global Modular Replacement System Proximal Femoral Resection for Large Segmental Replacements, Femur Prosthesis Surgical Literature, Stryker Orthopaedics, Mahwah, NJ 07430
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA