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
Pin, Fixation, Threaded - Product Code JDW
원인
The pin may fail because the metal used to make the pin does not meet the firm's hardness specification.
조치
All affected U.S. accounts were sent a letter dated October 15, 2003 by certified mail, return receipt requested. The seven foreign initial consignee accounts were notified via electronic mail. Customers were asked to return non-implanted product and to advise the implanting surgeons of the problem so that they may take appropriate action in regard to their patients.
The majority of the pins were distributed within the United States. Distribution also occured in seven foreign countries; Taiwan, Canada, Japan, Korea, Belgium, Australia and Finland.
제품 설명
Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 4 1/4 inches in length. Catalog # 281-01-08.