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
Prothesis Ankle - 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 Ankle, Titanium Alloy, Sterilized, BP Ankle System. || BP Ankle System, B-P Type II Talar Ankle Component: || Size 1 B-P Type II Talar Ankle Component Catalog: 05-01-0101, || Size 2 B-P Type II Talar Ankle Component Catalog: 05-01-0102, || Size 3 B-P Type II Talar Ankle Component Catalog: 05-01-0103, || Size 4 B-P Type II Talar Ankle Component Catalog: 05-01-0104, || Size 5 B-P Type II Talar Ankle Component Catalog: 05-01-0105, || Size 6 B-P Type II Talar Ankle Component Catalog: 05-01-0106. || BP Ankle System, BP Type II Ankle Bearing: || 3x5mm BP Type II Ankle Bearing Catalog: 05-02-0103, || 3x6mm BP Type II Ankle Bearing Catalog: 05-02-0113, || 3x7mm BP Type II Ankle Bearing Catalog: 05-02-0123, || 3x9mm BP Type II Ankle Bearing Catalog: 05-02-0143, || 3x11mm BP Type II Ankle Bearing Catalog: 05-02-0163, || 3x13mm BP Type II Ankle Bearing Catalog: 05-02-0183, || 4x5mm BP Type II Ankle Bearing Catalog: 05-02-0104, || 4x6mm BP Type II Ankle Bearing Catalog: 05-02-0114, || 4x7mm BP Type II Ankle Bearing Catalog:05-02-0124, || 5x5mm BP Type II Ankle Bearing Catalog: 05-02-0105, || 5x7mm BP Type II Ankle Bearing Catalog: 05-02-0125, || 5x9mm BP Type II Ankle Bearing Catalog: 05-02-0145. || 5x6mm BP Type II Ankle Bearing Catalog 05-02-0106. || 6x5mm BP Type II Ankle Bearing Catalog 05-02-0115. || 6x6mm BP Type II Ankle Bearing Catalog 05-02-0116. || 7x6mm BP Type II Ankle Bearing Catalog 05-02-0126. || 9x6mm BP Type II Ankle Bearing Catalog 05-02-0146. || 11x5mm BP Type II Ankle Bearing Catalog 05-02-0165. || 11x6mm BP Type II Ankle Bearing Catalog 05-02-0166. || 13x5mm BP Type II Ankle Bearing Catalog 05-02-0185. || 13x6mm BP Type II Ankle Bearing Catalog 05-02-0186. || BP Ankle System, B-P Type II Tibial Ankle Component || Size 1 B-P Type II Tibial ankle Component Catalog: 05-03-0101, || Size 2 B-P Type II Tibial ankle Component Catalog: 05-03-0102, || Size 3 B-P Type II Tibial ankle Component Catalog: 05-03-0103, || Size 4 B-P Type II Tibial ankle Component Catalog: 05-03-0104, || Size 5 B-P Type II Tibial ankle Component Catalog: 05-03-0105, || Size 6 B-P Type II Tibial ankle Component Catalog: 05-03-0106.