Events

Recall of Device Recall Moore Hip Prosthesis Long Fenestrated Stem

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
    68654
  • Event Risk Class
    Class 2
  • Event Number
    Z-2215-2014
  • Event Initiated Date
    2014-07-01
  • Event Date Posted
    2014-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128849
  • 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, femoral component, cemented, metal - Product Code JDG
  • Reason
    Zimmer is initiating a voluntary recall of 20 production lots of moore hip prosthesis long fenestrated stems due to packaging design verification test failures. specifically, 9 of 16 test samples failed simulated distribution and shipping testing when the moore hip stem breached either the inner or outer package tray. zimmer has not received any complaints of damaged package trays for these 20 lot.
  • Action
    On July 1, 2014 Zimmer, Inc. issued recall notification to their consignees via letter. This notice was issued to affected distributors and hospitals with instructions for returning the affected product. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory, as well as identifying hospitals and surgeons who have previously implanted the affected product and providing related contact information (name, address, and phone number). Distributors are to return on-hand affected products to Zimmer and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons were provided with a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product and returning it to their Zimmer sales representative.

Device

Device Recall Moore Hip Prosthesis Long Fenestrated Stem
  • Model / Serial
    Part 00402100838, Lot 62435853; Part 00402100841, Lot 62435854; Part 00402100843, Lot 62396506; Part 00402100844, Lot 62424468; Part 00402100848, Lot 62435852; Part 00402100848, Lot 62467218; Part 00402100848, Lot 62511381; Part 00402100851, 37108214; Part 00402100852, Lot 62511377; Part 00402100854, Lot 62511379; Part 00402101241, Lot 62352570; Part 00402101244, Lot 62424469; Part 00402101246, Lot 62400669; Part 00402101248, Lot 62400670; Part 00402101249, Lot 62467222; Part 00402101251, Lot 62470576; Part 00402101252, Lot 62435851; Part 00402101254, Lot 62424470; Part 00402101257, Lot 62524114; & Part 00402101260, Lot 62524115.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US (nationwide) in the states of IN, WI, MN, OR, and TX, and one foreign consignee in Canada.
  • Product Description
    Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length. || Product Usage: || The Moore Hip Prosthesis is a femoral him stem that can be used where there is roentgenogrpahic evidence of a satisfactory actabulum and sufficient bone in the femoral neck to seat the prosthesis with or without bone cement.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Manufacturer Address
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA