Events

Recall of Sirus

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
    33810
  • Event Risk Class
    Class 2
  • Event Number
    Z-0091-06
  • Event Date Posted
    2005-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42483
  • 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
    Bit, Surgical - Product Code GFG
  • Reason
    The calibrations on the reamers may lead to inaccurate reaming depth when used in accordance with the published surgical technique.
  • Action
    Consignees were notified via recall letter dated 9/30/05.

Device

Sirus
  • Model / Serial
    Lots 480103, 480104 and 487665.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah and Virginia.
  • Product Description
    Zimmer brand Sirus Intramedullary femur nail system step reamer 0 mm, 6.5/4.5 mm cannulated, for cervical screws, item number 02.00020.039.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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