Events

Recall of Device Recall LFIT COCR V40 Femoral Head; xxLong (16mm) Neck Length 32mm Diameter

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
    45902
  • Event Risk Class
    Class 2
  • Event Number
    Z-0967-2008
  • Event Initiated Date
    2007-11-02
  • Event Date Posted
    2008-02-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68196
  • 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
    Semi-Constrained Metal/Polymer Cemented Hip Prosthesis - Product Code JDI
  • Reason
    Fracture of stem neck - the firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures when a v40 +16mm offset femoral head is mated with certain accolade tmzf femoral stems in patients classified as overweight or obese.
  • Action
    Stryker Orthopaedics sent an Urgent Product Recall notification letters on November 9, 2007, by Federal Express with return receipt. The letter informed users of potential increased risk of stem neck fracture, when a V40 + 16mm offset femoral head is mated with certain Accolade TMZF femoral stems in patients classified as overweight or obese. The firm has asked that inventory be examined, removed and held in quarantine. A Stryker representative will contact the medical facilities to retrieve the product. If a representative has not contacted the facility to date, it is suggested that they contact Stryker at (201) 831-5972.

Device

Device Recall LFIT COCR V40 Femoral Head; xxLong (16mm) Neck Length 32mm Diameter
  • Model / Serial
    V40 COCR LFIT HEAD 32mm/+16-- Product Number: 6260-9-532 All Lot Codes
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Stryker LFIT COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 32mm Diameter Sterile, Forged Vitallium Alloy Product Number 6260-9-532 || Howmedica Osteonics Corp. Styrker Ireland; Carrigtwohill county Cork, Ireland. || Made in Ireland.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA