Events

Recall of Device Recall Gamma3

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
    51409
  • Event Risk Class
    Class 2
  • Event Number
    Z-1351-2009
  • Event Initiated Date
    2009-03-02
  • Event Date Posted
    2009-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80218
  • 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
    Operative Technique for Hip Fracture System - Product Code JDS
  • Reason
    Operative technique: further clarification and guidance is needed to help reduce the potential for distal mis-drilling of the short gamma3 trochanteric nails.
  • Action
    Stryker sent Urgent Product Recall letters by Federal Express on March 2, 2009 to Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. Letters were sent to all who have used the Gamma3 products in the past.

Device

Device Recall Gamma3
  • Model / Serial
    Catalog number LG3-OT, no lot numbers, this is the surgical technique brochure.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide.
  • Product Description
    Stryker, Gamma3, The Compact Version of the Gamma Nail System, Operative Technique for Hip Fracture System, Trochanteric and Long Nails.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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