Events

Recall of Device Recall Zimmer Sirus Intramedullary Nail for Tibia

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer Inc..

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
    51687
  • Event Risk Class
    Class 2
  • Event Number
    Z-1261-2009
  • Event Initiated Date
    2009-03-23
  • Event Date Posted
    2009-05-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80977
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Reason
    The package is labeled as containing 330 mm length nails, but actually contains 300 mm length nails.
  • Action
    Distributors were initially notified by phone on March 23, 2009. Distributors and user accounts were notified by an "Urgent: Device Recall" letter dated March 31, 2009. The letter described the affected product, reason for recall, risks to health, other information and actions for customers. Customers were instructed to quarantine recalled product and to return it to the Zimmer Distribution Center. For questions about the recall, contact Zimmer, Inc. at 1-800-613-6131.

Device

Device Recall Zimmer Sirus Intramedullary Nail for Tibia
  • Model / Serial
    Lot Number 2385866.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US (states of Florida, Missouri, New Jersey, New York, Ohio, Oklahoma and Texas) and countries of Austria, Japan, Korea and Germany.
  • Product Description
    Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile, Zimmer GmbH, Winterthur, Switzerland; REF 02.02631.233. || The device is used in orthopedic trauma surgeries for stabilization of tibial bone fractures.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Manufacturer Address
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA