Prosthesis Hip (Endotec) - Sterility Issues (2009)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Endotec Prothesis Hip, Titanium Alloy, Sterilized. Acetabular Bearing, BP Hip System Component: 32x54 Acetabular Bearing, Catalog: 01-02-3254, 32x56 Acetabular Bearing, Catalog: 01-02-3256, Femoral Head Resurfacing Component, BP Hip System Component: 36.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0036, 38mm Femoral Head Resurfacing Component:, Catalog: 01-03-0038, 39.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0039, 41mm Femoral Head Resurfacing Component:, Catalog
Brand
Endotec, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot No: 01023254CNN379 01023256CNN379 01030036ENN351 01030036ENN363 01030038ENN363 01030038ENN351 01030039G1NN363 01030039G1NN351 01030041FNN363 01030041FNN351 01030042ENN351 01030042ENN363 01030044CNN351 01030044CNN363 01030045HNN363 01030045HNN351 01030047G2NN363 01030047HNN351 01030049H2NN363 01030049H2NN351 01030051F1NN363 01030051F1NN351 01030052F1NN363 01030052F1NN351 01040110SNN330 01040111JNN353 01040111QNN330 01040112XNN330 01040112YNN353 01040112YNN326
Endotec, Inc. is recalling Endotec Prothesis Hip, Titanium Alloy, Sterilized. Acetabular Bearing, BP Hip System Component: 32x 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