Events

Recall of Device Recall SC2316, Distal Femoral Augment with Screw

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
    65823
  • Event Risk Class
    Class 2
  • Event Number
    Z-2136-2013
  • Event Initiated Date
    2013-06-24
  • Event Date Posted
    2013-09-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120308
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of sc2316, distal femoral augment with screw.
  • Action
    Stelkast called and emailed all customers on June 24, 2013, to notify them of the recall. Customers were asked to recover all affected products from their inventory and return them to Stelkast. Customers were instructed to contact Stelkast Customer Service for a Return Authorization (RA) Number prior to shipment to Stelkast. Customers with questions were instructed to call 1-888-273-1583. For questions regarding this recall call 724-941-6368.

Device

Device Recall SC2316, Distal Femoral Augment with Screw
  • Model / Serial
    Part number SC2316-3-5 with lot number 22389-111609. Part number SC2316-4-5 with lot number 22587-111609. Part number SC2316-5-5 with lot number 23214-111609.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including TX, VA, OK, and PA
  • Product Description
    SC2316, Distal Femoral Augment with Screw || Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
  • 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