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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Recall
see related information
Date Posted May 20, 2010
Recall Status1 Terminated on October 22, 2013
Recall Number Z-1625-2010
Recall Event ID 52527
Premarket Notification
510(K) Numbers
K012702  K842234  K904870  K904880  K960425 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product 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.
Code Information Lot No: 05010031BNN376 05010032BNN376 05010033BNN376 05010033CNN376 05120031BNN376 05120032BNN377 05120033BNN376 05130532BNN377 05130732BNN377 05130533BNN376 05130731BNN376
Recalling Firm/
Manufacturer
Endotec, Inc.
2546 Hansrob Rd
Orlando, Florida 32804-3318
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/UNDETERMINED: Pending
Action Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.
Quantity in Commerce 50 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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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