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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 Device Recall Endotec, Prosthesis Hip 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-1623-2010
Recall Event ID 52527
510(K)Number K963101  
Product Classification Prosthesis Hip - 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 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 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 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.
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