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Class 2 Device Recall Endotec, Prosthesis Shoulder |
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Date Initiated by Firm |
June 05, 2009 |
Date Posted |
May 20, 2010 |
Recall Status1 |
Terminated 3 on October 22, 2013 |
Recall Number |
Z-1622-2010 |
Recall Event ID |
52527 |
510(K)Number |
K904880
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Product Classification |
Prosthesis Shoulder - Product Code JWH
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Product |
Endotec Prosthesis Shoulder, Titanium Alloy, Sterilized
Modular Femoral Stem BP Shoulder Component: 12mm Modular Femoral Stem, Catalog: 02-21-0103, Lot 02-21-0103ANN374.
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Code Information |
Catalog: 02-21-0103ANN374, |
Recalling Firm/ Manufacturer |
Endotec, Inc. 2546 Hansrob Rd Orlando FL 32804-3318
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For Additional Information Contact |
407-822-0021
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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.
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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 |
3 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 and Original Applicant = ENDOTEC, INC.
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