| Class 2 Device Recall Endotec Prothesis Ankle | |
Date Initiated by Firm | June 05, 2009 |
Date Posted | May 20, 2010 |
Recall Status1 |
Terminated 3 on October 22, 2013 |
Recall Number | Z-1627-2010 |
Recall Event ID |
52527 |
510(K)Number | K842234 K904870 K960425 |
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 510(K)s with Product Code = JWH
|
|
|
|