Events

Recall of Stanmore modular hip system; Stanmore CoCr femoral size 5 std. stem; part 164245

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet, 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
    26618
  • Event Risk Class
    Class 2
  • Event Number
    Z-1285-03
  • Event Initiated Date
    2003-06-18
  • Event Date Posted
    2003-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28003
  • 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
    The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
  • Action
    Distributors were sent a letter on June 18, 2003 via FedEx. This mailing contained labels and the distributors were instructed to affix the label to the inventory consigned to hospitals within their territory.

Device

Stanmore modular hip system; Stanmore CoCr femoral size 5 std. stem; part 164245
  • Model / Serial
    lots 197284, 211992, 211998, 225646, 226431, 233479, 233677, 251871, 255929, 266786, 269741, 279430, 286358, 292600, 292735, 326453, 336746
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    United States
  • Product Description
    Stanmore modular hip system; Stanmore CoCr femoral size 5 std. stem; part 164245
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 East Bell Drive, Warsaw IN 46582
  • Source
    USFDA