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.
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 Ankle, Titanium Alloy, Sterilized, BP Ankle System. || BP Ankle System, F-P Type III Ankle Bearing Component: || 2x5mm F-P Type III Ankle Bearing Catalog: 05-13-0532, || 2x7mm F-P Type III Ankle Bearing Catalog: 05-13-0732, || 8x3mm F-P Type III Ankle Bearing Catalog: 05-13-0533, || 8x1mm F-P Type III Ankle Bearing Catalog: 05-13-0731. || BP Ankle System, F-P Type III Tibial Ankle Component: || Size 1 F-P Type III Tibial Component Catalog: 05-12-0031, || Size 2 F-P Type III Tibial Component Catalog: 05-12-0032, || Size 3 F-P Type III Tibial Component Catalog: 05-12-0033. || BP Ankle System, F-P Type III Talar Component: || Size 1 F-P Type III Talar Component Catalog: 05-01-0031, || Size 2 F-P Type III Talar Component Catalog: 05-01-0032, || Size 3 F-P Type III Talar Component Catalog: 05-01-0033.