Events

Recall of Proven Knee Tibial Augmentation and 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
    45528
  • Event Risk Class
    Class 3
  • Event Number
    Z-0482-2008
  • Event Initiated Date
    2007-10-05
  • Event Date Posted
    2008-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65738
  • 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
    Tibial Half Block with Screw - Product Code JWH
  • Reason
    The screws may fracture.
  • Action
    The recalling firm telephoned their customers on 10/5/07 to inform them of the problem and the need to return the product. As a follow up to the telephone calls, the recalling firm issued a recall letter (Field Notification) on 10/9/07 via certified mail.

Device

Proven Knee Tibial Augmentation and Screw
  • Model / Serial
    Lot Numbers: 14894-122005, 16040-010906, 16054-031406, 17945-043007, and 17945-050107.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide: shipped to medical facilities in IL, NC, PA, TN, TX, VA, and WV.
  • Product Description
    StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-4-5, Size 4, Thickness 5 mm, StelKast, Murray, PA 15317
  • 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