Events

Recall of Proven Porous CR Femur

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
    30287
  • Event Risk Class
    Class 2
  • Event Number
    Z-0496-05
  • Event Date Posted
    2005-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35614
  • 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
    Sterility may be compromised. the inner pouch of the implant packaging was sticking out beyond the seal of the outer pouch.
  • Action
    The recalling firm telephoned their customers 9/24/04 to inform them of the problem and the need to return the product. As a follow up to the telephone call, the recalling firm sent fax notifications to their customers. The medical supply companies were instructed to contact their customers.

Device

Proven Porous CR Femur
  • Model / Serial
    Catalog number SC2113-2 Lot number 3763-012501, Catalog number SC2113-3 Lot number 3764-012501, Catalog number SC2113-4 Lot number 3765-012501, Catalog number SC2113-1 Lot number 3762-012501, Catalog number SC2113-6 Lot number 3767-012501, Catalog number SC2113-5 Lot number 3766-012501, Catalog number SC2114-4 Lot number 3771-012501, Catalog number SC2114-3 Lot number 3770-012501, Catalog number SC2114-1 Lot number 3768-012501, Catalog number SC2114-2 Lot number 3769-012501, Catalog number SC2114-6 Lot number 3773-012501, and Catalog number SC2114-5 Lot number 3772-012501.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The product was shipped to medical supply companies in CA, MO, NC, and WV and sales representatives in AZ , NC and PA.
  • Product Description
    Proven Porous CR Femur. Implantable orthopedic device
  • 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