Events

Recall of TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.

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
    25007
  • Event Risk Class
    Class 2
  • Event Number
    Z-0170-04
  • Event Initiated Date
    2002-09-09
  • Event Date Posted
    2003-11-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25008
  • 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
    Inaccurate dimensions of the device. offshore manufacturer recalled product, some of which have been implanted.
  • Action
    Certified letters were sent out to the 2 providers that had implanted the device. The remaining inventory was exported back to the manufacturer.

Device

TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.
  • Model / Serial
    Lot 0006.13.2635
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    TX,
  • Product Description
    TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.
  • Manufacturer
    Plus Orthopedics

Manufacturer

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