Events

Recall of Device Recall VKS Knee System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Plus Orthopedics USA.

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
    34255
  • Event Risk Class
    Class 3
  • Event Number
    Z-0397-06
  • Event Initiated Date
    2005-12-02
  • Event Date Posted
    2006-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43345
  • 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 adjustment knob tower on one device was found to have broken off from the body of the instrument. this did not happend during a surgery and is believed to have been caused by the instrument being dropped or otherwise mishandled during hospital processing. a manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification.
  • Action
    The adjustment know tower on one device was found t have broken off from the body of the instrument. This did not happend during a surgery, and is belived tohave been caused by the instrument being dropped or otherwise mishandled during hospital processing. A manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification.

Device

Device Recall VKS Knee System
  • Model / Serial
    PI.79;  PI.79/I;  PI.79/IIII;  PI.80;  PI.80/III;  PI.80/IIII;  PI.80/IIIII
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Arizona, California, Colorado, Idaho, New York, Oklahoma, Texas, Utah, Wisconsin
  • Product Description
    VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument)
  • Manufacturer
    Plus Orthopedics USA

Manufacturer

Plus Orthopedics USA
  • Manufacturer Address
    Plus Orthopedics USA, 10188 Telesis Ct, San Diego CA 92121-4779
  • Source
    USFDA