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-1627-2010
  • 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=85098
  • 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: 05010101ANN364 05010101BNN364 05010102BNN364 05010103BNN364 05010104ANN364 05010104BNN364 05010105ANN364 05010105BNN364 05010106ANN364 05010106BNN364 05020103DNN377 05020103DNN385 05020103NN377 05020104DNN377 05020104DNN385 05020105DNN376 05020105DNN385 05020113ANN377 05020114ANN377 05020123DNN377 05020123DNN385 05020124DNN377 05020124DNN385 05020125DNN376 05020125DNN385 05020143DNN377 05020143DNN385 05020145DNN385 05020163NN377 05020183DNN377 05030101BNN364 05030102BNN364 05030103BNN358 05030103BNN364 05030104A2NN364 05030104ANN364 05030104BNN358 05030104BNN364 05030105BNN364 05030106BNN364  05020106DNN376  05020115ANN376  05020116ANN376  05020126DNN376  05020146DNN376  05020165DNN376  05020166DNN376  05020185DNN376  05020186DNN376
  • 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, B-P Type II Talar Ankle Component: || Size 1 B-P Type II Talar Ankle Component Catalog: 05-01-0101, || Size 2 B-P Type II Talar Ankle Component Catalog: 05-01-0102, || Size 3 B-P Type II Talar Ankle Component Catalog: 05-01-0103, || Size 4 B-P Type II Talar Ankle Component Catalog: 05-01-0104, || Size 5 B-P Type II Talar Ankle Component Catalog: 05-01-0105, || Size 6 B-P Type II Talar Ankle Component Catalog: 05-01-0106. || BP Ankle System, BP Type II Ankle Bearing: || 3x5mm BP Type II Ankle Bearing Catalog: 05-02-0103, || 3x6mm BP Type II Ankle Bearing Catalog: 05-02-0113, || 3x7mm BP Type II Ankle Bearing Catalog: 05-02-0123, || 3x9mm BP Type II Ankle Bearing Catalog: 05-02-0143, || 3x11mm BP Type II Ankle Bearing Catalog: 05-02-0163, || 3x13mm BP Type II Ankle Bearing Catalog: 05-02-0183, || 4x5mm BP Type II Ankle Bearing Catalog: 05-02-0104, || 4x6mm BP Type II Ankle Bearing Catalog: 05-02-0114, || 4x7mm BP Type II Ankle Bearing Catalog:05-02-0124, || 5x5mm BP Type II Ankle Bearing Catalog: 05-02-0105, || 5x7mm BP Type II Ankle Bearing Catalog: 05-02-0125, || 5x9mm BP Type II Ankle Bearing Catalog: 05-02-0145. || 5x6mm BP Type II Ankle Bearing Catalog 05-02-0106. || 6x5mm BP Type II Ankle Bearing Catalog 05-02-0115. || 6x6mm BP Type II Ankle Bearing Catalog 05-02-0116. || 7x6mm BP Type II Ankle Bearing Catalog 05-02-0126. || 9x6mm BP Type II Ankle Bearing Catalog 05-02-0146. || 11x5mm BP Type II Ankle Bearing Catalog 05-02-0165. || 11x6mm BP Type II Ankle Bearing Catalog 05-02-0166. || 13x5mm BP Type II Ankle Bearing Catalog 05-02-0185. || 13x6mm BP Type II Ankle Bearing Catalog 05-02-0186. || BP Ankle System, B-P Type II Tibial Ankle Component || Size 1 B-P Type II Tibial ankle Component Catalog: 05-03-0101, || Size 2 B-P Type II Tibial ankle Component Catalog: 05-03-0102, || Size 3 B-P Type II Tibial ankle Component Catalog: 05-03-0103, || Size 4 B-P Type II Tibial ankle Component Catalog: 05-03-0104, || Size 5 B-P Type II Tibial ankle Component Catalog: 05-03-0105, || Size 6 B-P Type II Tibial ankle Component Catalog: 05-03-0106.
  • 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