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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 Posted May 20, 2010
Recall Status1 Terminated 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
407-822-0021
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 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.
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