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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 Anklesee related information
Date Initiated by FirmJune 05, 2009
Date PostedMay 20, 2010
Recall Status1 Terminated 3 on October 22, 2013
Recall NumberZ-1624-2010
Recall Event ID 52527
510(K)NumberK842234 K904870 K960425 
Product Classification Prothesis Ankle - Product Code JWH
ProductEndotec 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 
FEI Number 3004553437
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
ActionRecall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.
Quantity in Commerce43 Pieces
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = JWH
510(K)s with Product Code = JWH
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