Events

Recall of Device Recall Corin Unipolar Adapter Sleeve

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
    52713
  • Event Risk Class
    Class 3
  • Event Number
    Z-2144-2009
  • Event Initiated Date
    2009-06-26
  • Event Date Posted
    2009-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83769
  • 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, hemi-, femoral, metal - Product Code KWL
  • Reason
    The raw material used in the production of the unipolar adaptor sleeve and the restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by this vendor has raised concern about their supplied raw material. as a precaution and due to the potential impact on the mechanical properties of the products, st.
  • Action
    Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.

Device

Device Recall Corin Unipolar Adapter Sleeve
  • Model / Serial
    Catalog number: 570-000-01: CORIN UNIPOLAR ADAPTOR SLEEVE JW3MHE 25-Apr-2013 CORIN UNIPOLAR ADAPTOR SLEEVE JXNMHE 25-Apr-2013 CORIN UNIPOLAR ADAPTOR SLEEVE 8DHMJE 17-May-2013 CORIN UNIPOLAR ADAPTOR SLEEVE 8DKMJE 19-May-2013 CORIN UNIPOLAR ADAPTOR SLEEVE 8DVMJE 21-May-2013
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution
  • Product Description
    Corin Unipolar Adapter Sleeve, For use with Corin Unipolar CoCr Heads; Not for use w/ceramic heads; not for use w/ Stainless Steel implants. || Stryker Orthopaedics. || Indicated for use in partial hip replacement procedures for patients suffering from pain and disability due to a variety of related bone disease.
  • 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