Events

Recall of Device Recall Gamma 3 Long Nail Kit R2.0

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
    56364
  • Event Risk Class
    Class 2
  • Event Number
    Z-2340-2010
  • Event Initiated Date
    2010-07-23
  • Event Date Posted
    2010-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93304
  • 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
    Intramedullary Fixation Rod and Accessories - Product Code HSB
  • Reason
    The nail has no thread for the set screw hindering insertion.
  • Action
    Urgent Product Recall letters were sent on July 23, 2010 by Federal Express to Stryker branches. A corrected letter was sent on July 26, 2010 to correct an error in the size of the screw. Additionally, letters were sent on July 26, 2010 to Hospital Risk Managers, Chief of Orthopaedics and Surgeons. The letter identified the affected product, explained the issue, discussed the potential hazard, and the risk mitigation. Customers are to examine their inventory, retrieve all affected product and return it; then reconcile all products on the Product Recall Acknowledgement Form and fax it back. Questions should be directed towards Richard Wolyn at 201-972-2100.

Device

Device Recall Gamma 3 Long Nail Kit R2.0
  • Model / Serial
    Lot code K248963; Expiration: 8/14/2014.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- NJ, NY, DE, IN, WI, IL, PA and NM.
  • Product Description
    Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees; || Sterile, TI Alloy, Implant; Catalog number 3225-0360S. || Stryker Trauma GmbH, 24232 Schenjrchen, Germany; || distributed in USA by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430. || Intended for temporary fixation, correction, or stabilization of the right femur.
  • 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