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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 Posted May 20, 2010
Recall Status1 Terminated 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 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.
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