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
The medical device is misbranded in that the package is labeled as biosteon interference screw in fact contains biosteon cross pin. this mislabeling could disrupt surgery preparation resulting in surgery delay.
조치
On 8/23/05, all consignees were notified via telephone, written letter and also via sales representative, informing them of the affected product and providing instructions on the recall.
The product was distributed nationally to 8 consignees and internationally to 12 consignees via distributors and directly to physicians and/or medical facilities. Foreign countries include, Canada, Poland and Italy. It did not involve Defense Supply Center, VA or other Federal Government sales/distribution centers. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, physicians and medical facilities who received the recalled product.
제품 설명
Biosteon brand HA/PLLA Cross Pin, || Model Number 234-500-350; || Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138