Events

Recall of Device Recall Stelkast Unicondylar Knee Femoral Component SC24621

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stelkast Co.

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
    53772
  • Event Risk Class
    Class 2
  • Event Number
    Z-0371-2010
  • Event Initiated Date
    2009-05-05
  • Event Date Posted
    2009-11-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86492
  • 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
    Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. - Product Code HSX
  • Reason
    Incorrect size markings on component.
  • Action
    The recalling firm telephoned the medical supply companies on 5/5-19/09 to inform them of the problem and the need to return the products. If there are questions regarding this issue, please call 1.888.273.1583.

Device

Device Recall Stelkast Unicondylar Knee Femoral Component SC24621
  • Model / Serial
    Lot number 20210-100108
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Stelkast Unicondylar Knee Femoral Component SC2462-1. || Used for moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic; revision of failed unicompartmental knee implant or other procedure; and alternative to tibial osteotomy in patients with unicompartmental arthritis.
  • Manufacturer
    Stelkast Co

Manufacturer

Stelkast Co
  • Manufacturer Address
    Stelkast Co, 200 Hidden Valley Rd, Mcmurray PA 15317-2659
  • Manufacturer Parent Company (2017)
    Stelkast Inc.
  • Source
    USFDA