Events

Recall of Device Recall Howmedica Osteonics Corp. LFT v40 Femoral Head

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
    70338
  • Event Risk Class
    Class 2
  • Event Number
    Z-1241-2015
  • Event Initiated Date
    2015-02-03
  • Event Date Posted
    2015-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133157
  • 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, semi-constrained, metal/polymer, cemented - Product Code JDI
  • Reason
    Three customer complaints were received for the same batch of v40 lfit vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corresponding v40 stem trunnion.
  • Action
    Branches/Agencies were notified of this action by e-mail on December 19, 2014 and were asked to quarantine affected devices. Notification Letters and Product Accountability Forms were sent to Hospital Risk Management and Chief of Orthopaedics via FedEx (with return receipt) by 2/3/2015.

Device

Device Recall Howmedica Osteonics Corp. LFT v40 Femoral Head
  • Model / Serial
    Lot Code 48681201
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of GA, MA, NC, NY & PA.
  • Product Description
    LFT v40 Femoral Head; Catalog Number 6260-9-032; || V40 CoCr LFit Head 32mm/-4. || Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.
  • 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