Events

Recall of Device Recall UCPLUS Solution

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
    36237
  • Event Risk Class
    Class 2
  • Event Number
    Z-0192-2007
  • Event Initiated Date
    2006-07-18
  • Event Date Posted
    2006-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48235
  • 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, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer - Product Code HRY
  • Reason
    The modified devices were distributed by plus orthopedics usa (plus usa) june 10, 2003 prior to fda approval to market of the modified device (special 510(k) k032052, clearance date july 25, 2003) and withdrawn from the field june 25, 2003.
  • Action
    The depth of the withdrawal action taken in June, 2003 was to the distributor (agent) level. Plus USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA.

Device

Device Recall UCPLUS Solution
  • Model / Serial
    26014: Lot number 0305.13.2814, 26016: Lot number 0305.13.2815, 26018: Lot number 0305.13.2816, 26020: Lot number 0305.13.2817 Serial Number: None
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    California
  • Product Description
    UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10
  • Manufacturer
    Plus Orthopedics USA

Manufacturer

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