Events

Recall of Device Recall Restoration Modular Conical Distal Stem

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
    50498
  • Event Risk Class
    Class 2
  • Event Number
    Z-0884-2009
  • Event Initiated Date
    2008-11-21
  • Event Date Posted
    2009-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75529
  • 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 - Product Code LZO
  • Reason
    Stryker became aware of a lot for lot mix up.
  • Action
    Recall notification letters sent via Federal Express on Nov. 21, 2008 to Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeons. Letters explain the labeling mix up and the potential risks to patients if the wrong size stem is used. Stryker branches are asked to examine inventory and that of hospital locations to identify affected product. All affected product is to be reconciled on the Product Accountability form and the form faxed back to Stryker. Contact Stryker Howmedical Osteonics Corporation for additional information at 1-201-831-5718.

Device

Device Recall Restoration Modular Conical Distal Stem
  • Model / Serial
    Catalog No. 6276-7-017 (17mm), Lot Code CAXHA68D; Catalog No. 6276-7-014, (14mm) Lot Code CAXHB18A
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Class II Recall - Nationwide Distribution
  • Product Description
    Restoration Modular Conical Distal Stem; || Sterile, Titanium Alloy. One unit per package. || Stryker Ireland || Carrigtwohill County Cork, Ireland. || Authorized Representative in Europe: Stryker France, Cedex France. || This system is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of servere proximal bone loss.
  • 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