Events

Recall of Symmetric Total Knee Femoral Component

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

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
    69420
  • Event Risk Class
    Class 2
  • Event Number
    Z-0111-2015
  • Event Date Posted
    2014-10-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130498
  • 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
    Packaging of a device was compromised.
  • Action
    Signal Medical sent a Notice letter dated September 30, 2014 to customers. Customers were instructed to carefully inspect devices to ensure package integrity before using. If packaging is compromised it should not be used. Return the affected device and packaging to Signal Medical Corporation. Replacement devices with new packaging configuration is shipped to each location with the old packaging configuration in the event that the packaging is found to be compromised. For questions contact Signal Medical Corp. at 1-800-246-6324.

Device

Symmetric Total Knee Femoral Component
  • Model / Serial
    Catalog # 22-01-02106; Lot # 1110; Serial # L0259; Size 6R  Catalog #22-01-02106; Lot # 2910; Serial # L0533; Size 6R  Catalog # 22-01-02003, Serial #s L0280,L0283, L0284, L0285, L0287, L0288, L0615, Size 3 L  Catalog # 22-01-02004, Serial # l0358, Size 4L  Catalog # 22-01-02005, Serial # L0809; Size 5L  Catalog #22-01-02006; Serial #s L0692, L0842, L0485, L0483, L0486, L0841, L0844, L0847, Size 6L  Catalog # 22-01-02007, Serial #s L0721, L0786, L0787, L0770, L0772, L0775, Size 7L  Catalog #22-01-02103, Serial #s L0265, L0272, Size 3R  Catalog # 22-01-02104, Serial #s L0479, L0515, L0517, Size 4R  Catalog # 22/01-02106, Serial # L0338, L0508, L0537, L0853, L0867, L0872, L0873, Size 6R  Catalog #22-01-02107, Serial #s L0749, L0758, L0760, L0755, L0759, L0762, Size 7R
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama.
  • Product Description
    Symmetric Total Knee Femoral Components || Product Usage: || Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
  • Manufacturer
    Signal Medical Corporation

Manufacturer

Signal Medical Corporation
  • Manufacturer Address
    Signal Medical Corporation, 400 Pyramid Dr, Marysville MI 48040-2463
  • Manufacturer Parent Company (2017)
    Signal Medical Corporation
  • Source
    USFDA