Events

Recall of Device Recall Accolade Distal Spacer

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
    55213
  • Event Risk Class
    Class 2
  • Event Number
    Z-1594-2010
  • Event Initiated Date
    2010-03-31
  • Event Date Posted
    2010-05-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90334
  • 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
    orthopedic prosthesis component - Product Code JDI
  • Reason
    One lot of 13 mm medium distal ring centralizers and 14 mm large distal ring centralizer have been labeled incorrectly. the size 14 large centralizers have been labeled as size 13 medium centralizers and size 13 medium centralizers have been labeled as size 14 large centraliizers.
  • Action
    Notification letters and Product Accountability Forms have been sent to Stryker Orthopaedics Branch and Agencies via Fed Ex on March 31, 2010 with return receipt.. Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons were sent notificatio letters and Product Recall Acknowledgment Forms on April 1, 2010. with return reciept.

Device

Device Recall Accolade Distal Spacer
  • Model / Serial
    Catalog No.: 1059-4513 Lot Code: WDXMLE
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution.
  • Product Description
    Stryker Orthopaedics, Accolade Distal Centralizer 13 mm Medium; Catalog No.: 1059-4513. For use with Accolade hip prosthesis.
  • 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