Events

Recall of Device Recall Endotec Prothesis Ankle

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-1624-2010
  • 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=85066
  • 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
    Prothesis Ankle - 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 Prothesis Ankle
  • Model / Serial
    Lot No: 05010002ABNN320 05010002ABNN371 05010003BENN368 05010003BONN368 05010003BONN371 05010004AVNN371 05010005RNN371 05030002PNN371 05030003BENN323 05030003BENN371 05030004BFNN371 05030005AFNN371 05110002CNN371 051100031ENN371 05110003J2NN371 05110005GNN371
  • 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 Ankle, Titanium Alloy, Sterilized. || BP Ankle System, Talar Ankle Component: || Size 2 Talar Component Catalog: 05-01-0002, || Size 3 Talar Component Catalog: 05-01-0003, || Size 4 Talar Component Catalog: 05-01-0004, || Size 5 Talar Component Catalog: 05-01-0005, || BP Ankle System, Thick Talar Ankle Component: || Size 2 Thick Talar Component Catalog: 05-11-0002, || Size 3 Thick Talar Component Catalog: 05-11-0003, || Size 5 Thick Talar Component Catalog: 05-11-0005, || B-P Ankle System, Tibial Component: || Size 2 Tibial Component 05-03-0002, || Size 3 Tibial Component 05-03-0003, || Size 4 Tibial Component 05-03-0004, || Size 5 Tibial Component 05-03-0005,
  • 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