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
bone screw - Product Code HWC
원인
Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
조치
Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06.
Worldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE.
제품 설명
Zimmer Herbert Cannulated Bone Screw System Bone Screw, 4.5 mm dia., 25 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 47-1155-25-05 (47115502505).