Prosthesis Shoulder (Endotec) - Sterility Issues (2009)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Endotec, Inc.
Lot Codes / Batch Numbers
Catalog: 02-21-0103ANN374
Products Sold
Catalog: 02-21-0103ANN374,
Endotec, Inc. is recalling Endotec Prosthesis Shoulder, Titanium Alloy, Sterilized Modular Femoral Stem BP Shoulder Component: due to Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations a. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IN, NJ, OH, TN, TX
Page updated: Jan 10, 2026