Events

Recall of Device Recall Global Modular Replacement System (GMRS) Extension Piece 60 mm

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
    50095
  • Event Risk Class
    Class 2
  • Event Number
    Z-2624-2010
  • Event Initiated Date
    2005-05-05
  • Event Date Posted
    2010-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74715
  • 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
    Mislabeled package: package labeled as gmrs extension piece 60 mm, lot zycoc1 actually contains a gmrs extension piece 70 mm extension piece.
  • Action
    Stryker issued Important Market WIthdrawal letters dated May 5, 2005 to customers and distributors. The letters identified the affected product, the labeling issue, and actions to be taken by the customer or distributor. Customers were instructed to identify and quarantine affected product, which will be reconciled and returned by the Stryker sales representative. Distributors were instructed to identify affected product, reconcile all product on an attached Product Accountability Form to be faxed to Stryker at 201 831-4825 within two days of receipt of the letter. The affected product was to be returned using the enclosed pre-paid mailing label. Contact the Stryker sales representative to re-order product that is being returned. Stryker can be contacted at 201 831-5825.

Device

Device Recall Global Modular Replacement System (GMRS) Extension Piece 60 mm
  • Model / Serial
    Catalog number: 6495-6-060; Lot code LZYOC1
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution: USA, including the states of AZ, FL, MD, and PA.G
  • Product Description
    GMRS Extension Piece, 60 mm; Sterile || Stryker Howmedica Osteonics; Howmedica Internation S. de. R.L. Limerick, Ireland. || The Global Modular Replacement System is intended to be used with the components of the Howmedica Osteonics Modular Replacement System , the Howmedica Osteonics Modular Rotating Hinge Knee System and/or the Howmedica Osteonics Kinematic Rotating Hinge Knee System in situations where replacement of extensive bone loss in the femur and/or proximal tibia is required. The Proximal Femoral Module and Distal Femoral Module of the GMR may be used together, or with the components of the MRS, in replacement of the total femur.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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