• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Endotec, Prosthesis Knee

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Endotec, Prosthesis Knee see related information
Date Initiated by Firm June 05, 2009
Date Posting Updated May 20, 2010
Recall Status1 Terminated 3 on October 22, 2013
Recall Number Z-1621-2010
Recall Event ID 52527
510(K)Number K012702  
Product Classification Prosthesis Knee - Product Code JWH
Product Endotec, Prosthesis Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, Titanium Alloy, Sterilized, (Beuchel-Pappas (BP))

The B-P Knee Replacement System is composed of several components used to provide surgeons with different intra-operative options. All metallic components are available in six sizes and are fabricated from Ti-6Al-4V titanium alloy by Endotec.

BP Knee Replacement System Component, Modular Femoral Component:

Size 5 Left Modular Femoral Component, Catalog: 04-31-2105, Lot No. 04-31-2105A;
Size 4 Left Modular Femoral Component, Lot No. 04-31-2104A,
Size 6 Left Femoral Component, Lot No. 04-31-2106A1.

BP Knee Replacement System Component, Narrow Femoral Component:
Size 3 Right Narrow Femoral Component Lot No. 04-31-1303C,
Size 3 Left Narrow Femoral Component Lot No. 04-31-2303C,
Size 4 Right Narrow Femoral Component Lot No. 04-31-1304C,
Size 4 Left Narrow Femoral Component Lot No. 04-31-2304C.

BP Knee Replacement System Component, All Poly Patella:
Size 1 All Poly Patella Lot No. 04-34-0201B, 04-34-0201C, 04-34-0201D, 04-34-0201E.
Size 2 All Poly Patella Lot No. 04-34-0202B, 04-34-0202C, 04-34-0202D, 04-03-0202E.

BP Knee Replacement System Component, 3 Peg Patella:
Size 4 3-Peg Patella Lot No. 04-34-0004H.

BP Knee Replacement System Component, Conforming Bearing:
1x0mm Conforming Bearing Catalog: 04-33-001,
1x2.5mm Conforming Bearing Catalog: 04-33-0011,
1x5mm Conforming Bearing Catalog: 04-33-0021,
1x7.5mm Conforming Bearing Catalog: 04-33-0031,
2x0mm Conforming Bearing Catalog: 04-33-0002,
2x2.5mm Conforming Bearing Catalog: 04-33-0012,
2x5mm Conforming Bearing Catalog: 04-33-0022,
2x7.5mm Conforming Bearing Catalog: 04-33-0032,
3x0mm Conforming Bearing Catalog: 04-33-0003,
3x2.5mm Conforming Bearing Catalog: 04-33-0013,
3x5mm Conforming Bearing Catalog: 04-33-0023,
3x7.5mm Conforming Bearing Catalog: 04-33-0033,
4x0mm Conforming Bearing Catalog: 04-33-0004,
4x2.5mm Conforming Bearing Catalog: 04-33-0014,
4x5mm Conforming Bearing Catalog: 04-33-0024,
4x7.5mm Conforming Bearing Catalog: 04-33-0034,
5x0mm Conforming Bearing Catalog: 04-33-0005,
5x2.5mm Conforming Bearing Catalog: 04-33-0015
5x5mm Conforming Bearing Catalog: 04-33-0025,
5x7.5mm Conforming Bearing Catalog: 04-33-0035,
6x0mm Conforming Bearing Catalog: 04-33-0006,
6x2.5mm Conforming Bearing Catalog: 04-33-0016,

BP Knee Replacement System Component, Screw Stop:
Size 4-6 Screw Stop Catalog: 03-12-0036.

BP Knee Replacement System Component, Tibial Component Type 1 w/o Biocoat:
Size 1 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0401,
Size 2 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0402,
Size 3 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0403,
Size 4 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0404,
Size 5 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0405,
Size 6 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0406.

BP Knee Replacement System Component, Tibial Component Type 1:
Size 1 Type 1 Tibial Component Catalog: 04-32-0001,
Size 3 Type 1 Tibial Component Catalog: 04-32-0003,
Size 4 Type 1 Tibial Component Catalog: 04-32-0004.

BP Knee Replacement System Component, Tibial Component Type 2:
Size 3 Type 2 Tibial Component Catalog: 04-32-0013.

BP Knee Replacement System Component, Tibial Component Type 0:
Size 5 Type 0 Tibial Platform Catalog: 04-32-0065.

BP Knee Replacement System Component, Femoral Component w/o Biocoat:
Size 1 Right Femoral Component w/o Biocoat Catalog: 04-31-1201,
Size 1 Left Femoral Component w/o Biocoat Catalog:04-31-2201,
Size 2 Right Femoral Component w/o Biocoat Catalog: 04-31-1202,
Size 2 Left Femoral Component w/o Biocoat Catalog:04-31-2202,
Size 3 Right Femoral Component w/o Biocoat Catalog:04-31-1203,
Size 3 Left Femoral Component w/o Biocoat Catalog:04-31-2203,
Size 4 Right Femoral Component w/o Biocoat Catalog:04-31-
Code Information Lot No. , 03120036E1NN370, 04220001CNN320, 04311003JNN325, 04311003KNN344, 04311004INN390, 04311006DNN323, 04311201ANN335, 04311201BNN347, 04311201CNN375, 04311201CNN374, 04311201DNN384, 04311202BNN335, 04311202CNN341, 04311202D1NN370, 04311202D3NN365, 04311202DNN365, 04311202E1NN384, 04311203BNN340, 04311203CNN350, 04311203DNN368, 04311203D1NN360, 04311203ENN382, 04311203E1NN382, 04311204BNN337, 04311204CNN338, 04311204DNN375, 04311205BNN337, 04311205CNN341, 04311205DNN386, 04311205ENN386, 04311206ANN341, 04311303CNN344, 04311304CNN331, 04312003JNN324, 04312003KNN334, 04312005FNN320, 04312006DNN328, 04312104ANN362, 04312105ANN362, 04312106A1NN362, 04312201ANN335, 04312201BNN341, 04312201CNN384, 04312201DNN375, 04312202BNN335, 04312202CNN340, 04312202DNN365, 04312202D1NN375, 04312202D2NN366, 04312202ENN390, 04312202E2NN390, 04312202E3NN390, 04312202E4NN390, 04312203BNN340, 04312203CNN350, 04312203DNN375, 04312203D1NN360, 04312203D2NN382, 04312203D3NN382, 04312203E1NN388, 04312204ANN333, 04312204BNN335, 04312204CNN370, 04312205BNN340, 04312205CNN347, 04312205ENN386, 04312206ANN340, 04312303CNN334, 04312304CNN331, 043200013INN319, 04320003D1NN386, 04320004CNN330, 04320065A1NN331, 04320065A1NN319, 04320303ANN380, 04320401CNN344, 04320401DNN347, 04320401E1NN384, 04320402A1NN327, 04320402A2NN324, 04320402CNN347, 04320402DNN338, 04320402D1NN331, 04320402ENN372, 04320402E1NN383, 04320402E1NN365, 04320402E2NN370, 04320402E2NN376, 04320402E3NN365, 04320402F1NN381, 04320402FNN381, 04320402F2NN388, 04320402F3NN383, 04320403CNN344, 04320403DNN338, 04320403ENN361, 04320403E1NN370, 04320403E2NN377, 04320403E3NN372, 04320403FNN386, 04320403F2NN388, 04320403F3NN383, 04320403GNN366, 04320403G1NN372, 04320404CNN343, 04320404DNN337, 04320404ENN390, 04320404E1NN370, 04320405A1NN317, 04320405A2NN326, 04320405A3NN325, 04320405CNN351, 04320405DNN366, 04320405D1NN372, 04320405FNN391, 04320406A1NN321, 04320406A2NN324, 04320406CNN347, 04330001DNN321, 04330001ENN341, 04330001FNN348, 04330002FNN333, 04330002GNN333, 04330002HNN333, 04330002INN349, 04330002JNN361, 04330003GNN336, 04330003HNN333, 04330003INN337, 04330003JNN354, 04330003KNN352, 04330003LNN385, 04330004GNN317, 04330004HNN319, 04330004INN357, 04330004JNN357, 04330005GNN336, 04330005HNN379, 04330005INN361, 04330005JNN362, 04330005KNN359, 04330006HNN339, 04330011CNN332, 04330011DNN332, 04330011ENN341, 04330011FNN343, 04330012FNN341, 04330012GNN332, 04330012HNN333, 04330012INN353, 04330012JNN349, 04330012KNN387, 04330013GNN355, 04330013HNN341, 04330013INN345, 04330013INN348, 04330013JNN345, 04330013KNN350, 04330014GNN353, 04330014HNN327, 04330014INN320, 04330014KNN353, 04330015GNN361, 04330015HNN336, 04330015JNN352, 04330015KNN361, 04330016HNN339, 04330016INN339, 04330021CNN332, 04330021DNN337, 04330021ENN348, 04330021FNN341, 04330022FNN366, 04330022GNN334, 04330022HNN335, 04330022INN348, 04330022JNN348, 04330023GNN355, 04330023HNN322, 04330023INN332, 04330023JNN344, 04330023KNN348, 04330024GNN338, 04330024HNN334, 04330024JNN352, 04330025GNN336, 04330025HNN336, 04330025INN337, 04330031CNN333, 04330031DNN333, 04330031ENN347, 04330031FNN346, 04330032FNN343, 04330032GNN341, 04330032HNN358, 04330032JNN350, 04330032INN350, 04330032INN350, 04330033GNN339, 04330033INN332, 04330033JNN345, 04330033KNN349, 04330034HNN338, 04330034INN340, 04330034KNN350, 04330035GNN340, 04330035HNN336, 04330035KNN359, 04340003FNN359, 04340004HNN354, 04340201BNN328, 04340201CNN327, 04340201DNN362, 04340201ENN359, 04340202BNN322, 04340202CNN319, 04340202DNN358, 04340202ENN369, 04220001CNN320. .
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 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 3169 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 and Original Applicant = ENDOTEC, INC.
-
-