| Class 2 Device Recall | |
Date Initiated by Firm | June 05, 2009 |
Date Posted | May 20, 2010 |
Recall Status1 |
Terminated 3 on October 22, 2013 |
Recall Number | Z-1625-2010 |
Recall Event ID |
52527 |
510(K)Number | K842234 K904870 K960425 |
Product Classification |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
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Product | Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System.
BP Ankle System, F-P Type III Ankle Bearing Component:
2x5mm F-P Type III Ankle Bearing Catalog: 05-13-0532,
2x7mm F-P Type III Ankle Bearing Catalog: 05-13-0732,
8x3mm F-P Type III Ankle Bearing Catalog: 05-13-0533,
8x1mm F-P Type III Ankle Bearing Catalog: 05-13-0731.
BP Ankle System, F-P Type III Tibial Ankle Component:
Size 1 F-P Type III Tibial Component Catalog: 05-12-0031,
Size 2 F-P Type III Tibial Component Catalog: 05-12-0032,
Size 3 F-P Type III Tibial Component Catalog: 05-12-0033.
BP Ankle System, F-P Type III Talar Component:
Size 1 F-P Type III Talar Component Catalog: 05-01-0031,
Size 2 F-P Type III Talar Component Catalog: 05-01-0032,
Size 3 F-P Type III Talar Component Catalog: 05-01-0033. |
Code Information |
Lot No: 05010031BNN376 05010032BNN376 05010033BNN376 05010033CNN376 05120031BNN376 05120032BNN377 05120033BNN376 05130532BNN377 05130732BNN377 05130533BNN376 05130731BNN376 |
Recalling Firm/ Manufacturer |
Endotec, Inc. 2546 Hansrob Rd Orlando FL 32804-3318
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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 | 50 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 |
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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.
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510(K) Database | 510(K)s with Product Code = JWH 510(K)s with Product Code = JWH
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