Z-1624-2010

Endotec Prothesis Ankle, Titanium Alloy, Sterilized. BP Ankle System, Talar Ankle Component: Size 2 Talar...

Name: Z-1624-2010 Endotec Prothesis Ankle, Titanium Alloy, Sterilized. BP Ankle System, Talar Ankle Component: Size 2 Talar...
Creator: Endotec, Inc.
Published: 2009-06-05
License: https://open.fda.gov/license/

Endotec, Inc. / initiated 2009-06-05 / Terminated / root cause: sterility

FDA source

Endotec, Inc. began a recall of Endotec Prothesis Ankle, Titanium Alloy, Sterilized. BP Ankle System, Talar Ankle Component: Size 2 Talar Component Catalog: 05-01-0002, Size 3 Talar Component... on 2009-06-05. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1624-2010
Status: Terminated
Initiated: 2009-06-05
Posted: 2010-05-20
Terminated: 2013-10-22
Recalling firm: Endotec, Inc.
Product: 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,
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: 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.
Root cause tag: sterility
FDA root cause: Other
Action: Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.
Quantity in commerce: 43 Pieces
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 codes and lots: Lot No: 05010002ABNN320 05010002ABNN371 05010003BENN368 05010003BONN368 05010003BONN371 05010004AVNN371 05010005RNN371 05030002PNN371 05030003BENN323 05030003BENN371 05030004BFNN371 05030005AFNN371 05110002CNN371 051100031ENN371 05110003J2NN371 05110005GNN371

Product code JWH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)