Events

Recall of Device Recall Stelkast Crossover Acetabular Shell and Liner Hip System

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
    64505
  • Event Risk Class
    Class 2
  • Event Number
    Z-1066-2013
  • Event Initiated Date
    2013-01-24
  • Event Date Posted
    2013-04-07
  • 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=116365
  • 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
    Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented - Product Code OQG
  • Reason
    Firm was made aware of incidents relating to the difficulty of properly engaging and securing the cross-over 36mm liner into the cross-over shell.
  • Action
    The firm initiated their recall of this product on January 24, 2013 by notifying their consignees by telephone informing them of the recall.

Device

Device Recall Stelkast Crossover Acetabular Shell and Liner Hip System
  • Model / Serial
    Part Numbers SC3458-52, lot number 28820-112612; SC3474-52, lot number 28822-101812; SC3459-52, lot number 28823-101812; and SC3460-52, lot number 28821-000.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including the states of NV, OK and PA.
  • Product Description
    Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. || Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.
  • 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