Events

Recall of Device Recall Distal Centralizer Exeter II Hip 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
    55199
  • Event Risk Class
    Class 2
  • Event Number
    Z-1601-2010
  • Event Initiated Date
    2010-03-29
  • Event Date Posted
    2010-05-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90282
  • 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
    Hip Metal/Polymer Semi-Constrained Cemented Prosthesis - Product Code JDI
  • Reason
    Stryker became aware that device labels have incorrectly printed manufacture dates and thus incorrect expiration dates on the product label.
  • Action
    Urgent Product Recall letters and Product Accountability Forms have been sent via Fed Ex on March 29, 2010 with return receipt. Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeon were also sent Notification letters and Product Recall Acknowledgment Form on March 29, 2010 with return receipt. The letters explained the issue, the potential hazards, and risk mitigation. The firm asked customers to examine their inventory and hospital locations to identify the affected products. All affected product should be retrieved and returned to their branch or agency warehouse for reconciliation. The attached Product Accountability form should be used to reconcile all product(s) and it should be faxed back to 201-831-6069.

Device

Device Recall Distal Centralizer Exeter II Hip System
  • Model / Serial
    Lot code - L3988
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- FL, MN, & OR.
  • Product Description
    Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920. || Intended to be used to centralize the femoral stem within the intramedullary canal. intended to be used with bone cement.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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