|
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-1624-2010 |
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, Talar Ankle Component: Size 2 Talar Component Catalog: 05-01-0002, Size 3 Talar Component Catalog: 05-01-0003, Size 4 Talar Component Catalog: 05-01-0004, Size 5 Talar Component Catalog: 05-01-0005,
BP Ankle System, Thick Talar Ankle Component:
Size 2 Thick Talar Component Catalog: 05-11-0002, Size 3 Thick Talar Component Catalog: 05-11-0003, Size 5 Thick Talar Component Catalog: 05-11-0005,
B-P Ankle System, Tibial Component: Size 2 Tibial Component 05-03-0002, Size 3 Tibial Component 05-03-0003, Size 4 Tibial Component 05-03-0004, Size 5 Tibial Component 05-03-0005,
|
Code Information |
Lot No: 05010002ABNN320 05010002ABNN371 05010003BENN368 05010003BONN368 05010003BONN371 05010004AVNN371 05010005RNN371 05030002PNN371 05030003BENN323 05030003BENN371 05030004BFNN371 05030005AFNN371 05110002CNN371 051100031ENN371 05110003J2NN371 05110005GNN371 |
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 |
43 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.
|
|
|
|