Events

Recall of Device Recall Modular Hip and Knee Replacement System

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

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
    45947
  • Event Risk Class
    Class 2
  • Event Number
    Z-0926-2008
  • Event Initiated Date
    2007-11-15
  • Event Date Posted
    2008-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66563
  • 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
    Semi-Constrained Metal/Polymer Cemented Hip Prosthesis - Product Code JDI
  • Reason
    Curvature discrepancy -- the radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
  • Action
    On November 26, 2007, Stryker Sent Urgent Product Recall notification letters to Stryker Agencies/Branches and hospitals (OR Supervisor) by Federal Express. The notification requested that all inventory be examined and returned. Returning instructions were provided in the letter. Questions concerning this recall are being addressed by contacting the Regulatory Compliance Hotline at (201) 831-6633.

Device

Device Recall Modular Hip and Knee Replacement System
  • Model / Serial
    Catalog Number: 6485-3-715; Lot Codes: LCDCF, TEC056A, TEC056B, TEC088B, TEC088B1, TEC088C, TEC088E, TEC088H, TEC141, TEC142, TEC258, TEC338.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Stryker Modular Replacement System Curved Cemented Stem; || MRS 15x127 Curved Femoral Stem. Catalog Number: 6485-3-715; Stryker Orthopaedics Mahwah, NJ 07430
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA