Class 2 Device Recall Endotec, Prosthesis Shoulder

• Date Initiated by Firm: June 05, 2009
• Date Posted: May 20, 2010
• Recall Status: Terminated on October 22, 2013
• Recall Number: Z-1622-2010
• Recall Event ID: 52527
• 510(K)Number: K904880
• Product Classification: Prosthesis Shoulder - Product Code JWH
• 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.
• Code Information: Catalog: 02-21-0103ANN374,
• FEI Number: 3004553437
• 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: 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

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