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
Hip Prosthesis Femoral Head - Product Code LPH
원인
Mislabeled: a ten piece lot of 140-32-03, 12/14 bioloxforte alumina femoral heads 32mm (1069020 - 1069029), from ceramtec were incorrectly labeled as 140-28-03 12/14 bioloxforte alumina femoral heads, 28mm.
조치
Exactech issued a recall letter, titled Important Product Recall Notice on 10/31/2007 to the Distibutors that received the recalled product. It requested that all device recipients be notified and all product be returned to the firm.