Events

Recall of 17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial implant. || Part of the ''RT/RT Modular'' total knee replacement.

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

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
    27053
  • Event Risk Class
    Class 2
  • Event Number
    Z-0107-04
  • Event Initiated Date
    2003-08-01
  • Event Date Posted
    2003-11-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29087
  • 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, Constrained, Cemented, Metal/Polymer - Product Code KRO
  • Reason
    Plastic insert over articular surface of knee joint replacement may become dislodged.
  • Action
    Firm telephoned each distributor to ensure that devices were not used in upcoming surgeries on 8/1 or 8/26/2003.

Device

17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial ...
  • Model / Serial
    No code information applies.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    AZ, ID, TX CTdistributors.
  • Product Description
    17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial implant. || Part of the ''RT/RT Modular'' total knee replacement.
  • Manufacturer
    Plus Orthopedics

Manufacturer

Plus Orthopedics
  • Manufacturer Address
    Plus Orthopedics, 6055 Lusk Blvd, San Diego CA 92121
  • Source
    USFDA