Events

Recall of Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32 mm dia., neck length +0mm

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
    31823
  • Event Risk Class
    Class 3
  • Event Number
    Z-1066-05
  • Event Initiated Date
    2005-04-15
  • Event Date Posted
    2005-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38573
  • 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
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
  • Reason
    May be mislabeled as to dimensions; may be 12/14 taper, 28mm dia., neck length +3.5mm.
  • Action
    Consignees were notified via certified letter dated 4/6/05.

Device

Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32 mm dia., neck length +0mm
  • Model / Serial
    Lot 60252787.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Canada.
  • Product Description
    Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32 mm dia., neck length +0mm; Product 00-8018-032-02.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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