U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Prosthesis Hip - Product Code JWH
원인
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.
조치
Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.
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.
제품 설명
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.