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U.S. Department of Health and Human Services

Class 2 Device Recall Endotec Prothesis Ankle

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  Class 2 Device Recall Endotec Prothesis Ankle see related information
Date Initiated by Firm June 05, 2009
Date Posting Updated May 20, 2010
Recall Status1 Terminated 3 on October 22, 2013
Recall Number Z-1624-2010
Recall Event ID 52527
510(K)Number K960425  K904870  K842234  
Product Classification Prothesis Ankle - Product Code JWH
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,
Code Information Lot No:, 05010002ABNN320, 05010002ABNN371, 05010003BENN368, 05010003BONN368, 05010003BONN371, 05010004AVNN371, 05010005RNN371, 05030002PNN371, 05030003BENN323, 05030003BENN371, 05030004BFNN371, 05030005AFNN371, 05110002CNN371, 051100031ENN371, 05110003J2NN371, 05110005GNN371.
Recalling Firm/
Manufacturer
Endotec, Inc.
2546 Hansrob Rd
Orlando FL 32804-3318
For Additional Information Contact
407-822-0021
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ENDOMEDICS, INC.
510(K)s with Product Code = JWH and Original Applicant = ENDOTEC, INC.
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