Events

Recall of Device Recall Endotec, Prosthesis Hip

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

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
    52527
  • Event Risk Class
    Class 2
  • Event Number
    Z-1623-2010
  • Event Initiated Date
    2009-06-05
  • Event Date Posted
    2010-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84495
  • 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 Hip - Product Code JWH
  • Reason
    Endotec is recalling b-p hip, b-p shoulder, and b-p knee replacement system devices due to sterility issues involving validation, process variations and test results.
  • Action
    Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.

Device

Device Recall Endotec, Prosthesis Hip
  • Model / Serial
    Lot No: 01023254CNN379 01023256CNN379 01030036ENN351 01030036ENN363 01030038ENN363 01030038ENN351 01030039G1NN363 01030039G1NN351 01030041FNN363 01030041FNN351 01030042ENN351 01030042ENN363 01030044CNN351 01030044CNN363 01030045HNN363 01030045HNN351 01030047G2NN363 01030047HNN351 01030049H2NN363 01030049H2NN351 01030051F1NN363 01030051F1NN351 01030052F1NN363 01030052F1NN351 01040110SNN330 01040111JNN353 01040111QNN330 01040112XNN330 01040112YNN353 01040112YNN326
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution -- US in OH, TX, CA, FL, NJ, TN; and International Distribution: Korea, Australia, Switzerland, The Netherlands, Spain. Domestic: OH, TX, CA, FL, NJ, TN.
  • Product Description
    Endotec Prothesis Hip, Titanium Alloy, Sterilized. || Acetabular Bearing, BP Hip System Component: || 32x54 Acetabular Bearing, Catalog: 01-02-3254, || 32x56 Acetabular Bearing, Catalog: 01-02-3256, || Femoral Head Resurfacing Component, BP Hip System Component: || 36.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0036, || 38mm Femoral Head Resurfacing Component:, Catalog: 01-03-0038, || 39.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0039, || 41mm Femoral Head Resurfacing Component:, Catalog: 01-03-0041, || 42.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0042, || 44mm Femoral Head Resurfacing Component:, Catalog: 01-03-0044, || 45.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0045, || 47mm Femoral Head Resurfacing Component:, Catalog: 01-03-0047, || 49mm Femoral Head Resurfacing Component:, Catalog: 01-03-0049, || 51mm Femoral Head Resurfacing Component:, Catalog: 01-03-0051, || 52mm Femoral Head Resurfacing Component:, Catalog: 01-03-0052. || Femoral Stem BP Hip System Component: || 10mm Femoral Stem Catalog: 01-04-0110, || 11mm Femoral Stem Catalog: 01-04-0111, || 12mm Femoral Stem Catalog: 01-04-0112.
  • Manufacturer
    Endotec, Inc.

Manufacturer

Endotec, Inc.
  • Manufacturer Address
    Endotec, Inc., 2546 Hansrob Rd, Orlando FL 32804-3318
  • Manufacturer Parent Company (2017)
    Cellumed Co., Ltd.
  • Source
    USFDA