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U.S. Department of Health and Human Services

Class 2 Device Recall Endotec, Prosthesis Hip

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 Class 2 Recall
Endotec, Prosthesis Hip
see related information
Date Posted May 20, 2010
Recall Status1 Terminated on October 22, 2013
Recall Number Z-1623-2010
Recall Event ID 52527
Premarket Notification
510(K) Number
K963101 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
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: 01-03-0041, 42.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0042, 44mm Femoral Head Resurfacing Component:, Catalog: 01-03-0044, 45.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0045, 47mm Femoral Head Resurfacing Component:, Catalog: 01-03-0047, 49mm Femoral Head Resurfacing Component:, Catalog: 01-03-0049, 51mm Femoral Head Resurfacing Component:, Catalog: 01-03-0051, 52mm Femoral Head Resurfacing Component:, Catalog: 01-03-0052. Femoral Stem BP Hip System Component: 10mm Femoral Stem Catalog: 01-04-0110, 11mm Femoral Stem Catalog: 01-04-0111, 12mm Femoral Stem Catalog: 01-04-0112.
Code Information 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
Recalling Firm/
Manufacturer
Endotec, Inc.
2546 Hansrob Rd
Orlando, Florida 32804-3318
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/UNDETERMINED: Pending
Action Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.
Quantity in Commerce 51 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ENDOTEC, INC.
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