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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall 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-1625-2010
Recall Event ID 52527
510(K)Number K960425  K904870  K842234  
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
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
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

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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