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
Absorbable Bone Void Filler - Product Code MQV
원인
Lack of labeling precautions. calstrux¿ should not be used in combination with other products and the volume used should approximate the size of the defect. adverse reactions have been reported with over filling the defect site or combination product usage, including localized induration, swelling, inflammation, wound drainage, infection and device migration.
조치
On 8/25/06 Stryker notified consignees of the recall by letter and attached a new, revised package insert inside the mailing envelope