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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 Recall
Endotec Prothesis Ankle
see related information
Date Posted May 20, 2010
Recall Status1 Terminated on October 22, 2013
Recall Number Z-1627-2010
Recall Event ID 52527
Premarket Notification
510(K) Numbers
K842234  K904870  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, 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.
Code Information 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
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 156 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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