Events

Recall of Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System.

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-1625-2010
  • 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=85078
  • 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
    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

Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System.
  • Model / Serial
    Lot No: 05010031BNN376 05010032BNN376 05010033BNN376 05010033CNN376 05120031BNN376 05120032BNN377 05120033BNN376 05130532BNN377 05130732BNN377 05130533BNN376  05130731BNN376
  • 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. || BP Ankle System, F-P Type III Ankle Bearing Component: || 2x5mm F-P Type III Ankle Bearing Catalog: 05-13-0532, || 2x7mm F-P Type III Ankle Bearing Catalog: 05-13-0732, || 8x3mm F-P Type III Ankle Bearing Catalog: 05-13-0533, || 8x1mm F-P Type III Ankle Bearing Catalog: 05-13-0731. || BP Ankle System, F-P Type III Tibial Ankle Component: || Size 1 F-P Type III Tibial Component Catalog: 05-12-0031, || Size 2 F-P Type III Tibial Component Catalog: 05-12-0032, || Size 3 F-P Type III Tibial Component Catalog: 05-12-0033. || BP Ankle System, F-P Type III Talar Component: || Size 1 F-P Type III Talar Component Catalog: 05-01-0031, || Size 2 F-P Type III Talar Component Catalog: 05-01-0032, || Size 3 F-P Type III Talar Component Catalog: 05-01-0033.
  • 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