Events

Recall of Device Recall ZMR Trabecular Metal

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
    60419
  • Event Risk Class
    Class 2
  • Event Number
    Z-0366-2012
  • Event Initiated Date
    2011-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105374
  • 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
    Hip Prosthesis - Product Code LPH
  • Reason
    Lack of assurance of proper metal fatigue strength due to metal grain structure anomaly. in 2006 a recall was initiated as a result of the grain anomaly; however, these 4 lots had been split off during normal production and had not been included in the 2006 recall.
  • Action
    On 11/16/11, Zimmer sent letters titled "URGENT MEDICAL DEVICE RECALL" to distributors via electronic mail and to risk managers and surgeons via FedEx indicating that the product must be immediately removed from use and quarantined. " Stop using the affected lots and place affected product in quarantine. " Review available product on the shelf " Identify those part/lot combinations listed in the recall communication " Immediately remove any implants found that match part/lot combinations listed in the recall communication and quarantine " Return affected lots and signature of acknowledgement to Zimmer

Device

Device Recall ZMR Trabecular Metal
  • Model / Serial
    Item number: 00-7864-016-00 Lot number: 00104820
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA (NY), AUSTRALIA, SWITZERLAND, and DENMARK
  • Product Description
    Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Primary Hip Prosthesis Femoral Stem || SIZE 16 171 MM STEM LENGTH 12/14 NECK TAPER - STANDARD BODY - STANDARD NECK OFFSET TIVANIUM TI-6AL-4V ALLOY/TANTALUM STERILE. Item number: 00-7864-016-00
  • Manufacturer
    Zimmer Inc.

Manufacturer

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