Events

Recall of Trabecular Metal acetabular Augments

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
    55364
  • Event Risk Class
    Class 2
  • Event Number
    Z-2217-2010
  • Event Initiated Date
    2010-04-06
  • Event Date Posted
    2010-08-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90689
  • 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, porous uncemented - Product Code LPH
  • Reason
    The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
  • Action
    The firm sent an "Urgent Device Removal" letter dated 4/6/2010. The consignees were instructed to inventory the products on hand and return the recalled product to the manufacturer. More information is available at 1-800-613-6131.

Device

Trabecular Metal acetabular Augments
  • Model / Serial
    60492197, 60704071, 60667465, 60728122, 60770944, 60796679, 60862513, 61081548, 61143008, and 61324533.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US, Germany, Brazil, Singapore, Canada, Australia, England, India, and Switzerland.
  • Product Description
    Trabecular Metal acetabular revision system column buttress right posterior/left anterior, 00-4894-400-00, sterile, Zimmer Inc., Parsippany, NJ.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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