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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-1627-2010
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.

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 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 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 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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