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
Screw, fixation, bone - Product Code HWC
원인
A recall of the aptus ulna shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt.
조치
The recall is being extended to end user level of distribution. The sales representatives, customers and a distributor were notified via phone or email on September 19th and notified of the recall via US mail on 10/1/14. US customers, distributors, and sales representatives were instructed to return the affected instrument kits to the importer Medartis, Inc. via transport agency.
US Nationwide Distribution in the states of WV, IL, CT, AZ, and WA.
제품 설명
APTUS Ulna Shortening 2.5 || Product Usage: || APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna.