Events

Recall of Modular Replacement System with Extra-Cortical Porous Coating, Femoral Module Stem and Tibial Module Stem

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Howmedica Osteonics.

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
    25460
  • Event Risk Class
    Class 2
  • Event Number
    Z-0588-03
  • Event Initiated Date
    2003-01-07
  • Event Date Posted
    2003-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26175
  • 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
    Some components have disassociated post-operatively resulting in additional surgery to the patient.
  • Action
    Notification letters were sent to Howmedica sales agents and Operating Room Supervisors via FedEx on 1/7/2003. On 2/12/2003, Howmedica again sent out notification letters on the extended recalled devices.

Device

Modular Replacement System with Extra-Cortical Porous Coating, Femoral Module Stem and Tibial Mod...
  • Model / Serial
    Catalog No. Lot No. Description  6485-3-008 D6JC SMALL FEMORAL STEM SECTION 8MM X 102MM; 6485-3-011 D6CDA FEMORAL MODULE STEM SECTION 11MM X 127MM; 6485-3-011 D6CDE FEMORAL MODULE STEM SECTION 11MM X 127MM; 6485-3-011 D6CDF FEMORAL MODULE STEM SECTION 11MM X 127MM; 6485-3-011 D6CEA FEMORAL MODULE STEM SECTION 11MM X 127MM; 6485-3-013 D6ADA FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6ADB FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6ADC FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFA FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFD FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFF FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFH FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFI FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFJ FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFK FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CGA FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CGF FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6NJA FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6NKB FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6NKC FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6NKD FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-015 D6CHA FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6CHC FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6CHE FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6CHF FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6GRB FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6GRC FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6GRD FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6GRE FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-017 D5YEF FEMORAL MODULE STEM SECTION 17MM X 127MM; 6485-3-311 D5YKAA FEMORAL MODULE 11MM X 203MM CURVED LONGSTEM; 6485-3-311 D5YKAB FEMORAL MODULE 11MM X 203MM CURVED LONGSTEM; 6485-3-311 D5YKAC FEMORAL MODULE 11MM X 203MM CURVED LONGSTEM; 6485-3-313 D6CBA FEMORAL MODULE 13MM X 203MM CURVED LONGSTEM; 6485-6-409 D5GBE TIBIAL MODULE STEM SECTION 9MM X 127MM; 6485-6-411 D5XWA TIBIAL MODULE STEM SECTION 11MM X 127MM.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The devices were distributed nationwide to Howmedica branches/agents, hospitals, one government hospital and internationally.
  • Product Description
    Modular Replacement System with Extra-Cortical Porous Coating, Femoral Module Stem and Tibial Module Stem
  • Manufacturer
    Stryker Howmedica Osteonics

Manufacturer

Stryker Howmedica Osteonics
  • Manufacturer Address
    Stryker Howmedica Osteonics, 300 Commerce Court, Mahwah NJ 07430
  • Source
    USFDA