Events

Recall of Device Recall MOST, Sulzer Orthopedics

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer Austin, 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
    30720
  • Event Risk Class
    Class 2
  • Event Number
    Z-0539-05
  • Event Initiated Date
    2004-12-17
  • Event Date Posted
    2005-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36453
  • 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, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer - Product Code KRO
  • Reason
    Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications.
  • Action
    The firm initiated the recall via letter on December 17, 2004. The firm''s letter requests the return of all recalled product.

Device

Device Recall MOST, Sulzer Orthopedics
  • Model / Serial
    Catalog Numbers: 5000-50-100 and 5000-50-200; Lot Numbers: 1529444, 1536181, 1538936, 1538937, 1542189, 1568350, 1568351, 1569597, 1596886, 1596890, 1601839, 1601841, 1610470, 1616609, and 1617691
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The product was distributed in AZ, CA, NY, IL, FL, MD, OH, MI, WI, MO, TX and to Canada and Portugal
  • Product Description
    MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer Austin, Inc., Austin, Texas 78717
  • Manufacturer
    Zimmer Austin, Inc

Manufacturer

Zimmer Austin, Inc
  • Manufacturer Address
    Zimmer Austin, Inc, 9900 Spectrum Dr, Austin TX 78717-4555
  • Source
    USFDA