Events

Recall of Device Recall Zimmer NEXGEN Tibial Broach Impactor

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
    48717
  • Event Risk Class
    Class 2
  • Event Number
    Z-2301-2008
  • Event Initiated Date
    2008-06-30
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71987
  • 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
    Broach Impactor - Product Code HWA
  • Reason
    The instrument may fracture during use, resulting in metal fragments being left in the patient post-surgery, which could cause implant failure.
  • Action
    Consignees were notified via letter dated 6/30/08. The letter described the issue, provided instructions for the return of the product and asked customers to complete a reply back form. For assistance, contact Zimmer at 1-574-372-4487.

Device

Device Recall Zimmer NEXGEN Tibial Broach Impactor
  • Model / Serial
    All units.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, China, England, France, Germany, India, Italy, Japan, Korea, Singapore and Taiwan.
  • Product Description
    Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor (a pounding instrument used during knee surgery), nonsterile, Zimmer, Warsaw, Indiana; REF 5951-90..
  • Manufacturer
    Zimmer Inc.

Manufacturer

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