Events

Recall of Proven Cemented Semi Constrained Total Knee

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
    49564
  • Event Risk Class
    Class 2
  • Event Number
    Z-0308-2009
  • Event Initiated Date
    2008-09-03
  • Event Date Posted
    2008-11-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73816
  • 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 patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. - Product Code JWH
  • Reason
    Five (5) three peg patella sc1591-29 were packaged in containers labeled for sc1591-38 sharing the same lot number.
  • Action
    On 9/4/08, the recalling firm telephoned their customers to inform them of the problem and asked them to immediately recover all SC1591-38 with lot number 19906-052008. Once the product is in their possession, customers should contact Stelkast Customer Service for a Return Authorization (RA) Number prior to shipment to Stelkast.

Device

Proven Cemented Semi Constrained Total Knee
  • Model / Serial
    Part number SC1591-38. Lot number 19906-052008
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution --- including states of IA and WV.
  • Product Description
    Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the thickness is 10 mm. || The Proven Knee System is a single use device intended for cemented reconstruction of the femoral and/or tibial portion of severely disabled and/or painful knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis with or without varus, valgus or flexion deformities, and revision surgery provided that there is radiographic evidence of sufficient sound bone to seat the prosthesis.
  • 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