Events

Recall of Device Recall Zimmer

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
    38468
  • Event Risk Class
    Class 2
  • Event Number
    Z-0316-2008
  • Event Initiated Date
    2007-06-28
  • Event Date Posted
    2007-12-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53817
  • 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
    Offset Rasp Handle - Product Code LXH
  • Reason
    Clip detachment: the retainer c-clip can detach from the instrument during use and may fall into the surgical wound.
  • Action
    Zimmer notified their distributors via Product Recall Notification Letter dated 6/30/07 and instructed them to notify their customers of the recall and to pick up the product and return it to Zimmer.

Device

Device Recall Zimmer
  • Model / Serial
    Lot No: 60646894.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.
  • Product Description
    Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Left, 45 degrees, non-sterile; REF/Catalog #: 7712-35-01, Zimmer U.K. Ltd., SN3, 4FP, UK
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Manufacturer Address
    Zimmer Inc., 345 E. Main St., Warsaw IN 46580-2304
  • Source
    USFDA