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
Manual Surgical Instrument for General Use - Product Code MDM
원인
Design flaw: issues were reported concerning fracture of handle, difficulty in removing inserter and inserter difficult to lock.
조치
Market Withdrawal letters were sent out on September 8, 2006 to all branches who received device. The letter asked customers to examine their inventory and hospital consignment locations to identify the product. Also, customers needed to reconcile all products on the attached Product Accountability Form and fax a copy back. The affected products were to be retrieved and returned using the "Product Returns Procedure".
Nationwide Distribution --- including state of NJ.
제품 설명
Stryker AVS AL Spacer Trial Inserter; || Non Sterile. Catalog number: 48329800 || Manufactured by Stryker Spine SAS, Cestas, France. || Distributed in USA by Osteonics Corp., Mahwah, NJ.