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
Passer, Wire, Orthopedic - Product Code HXI
원인
The wire appears to be soft and the wire bent during insertion. this causes kinks in which the reamer could not pass over the bent/kinked wire.
조치
The firm distributed a recall letter to their EBI Fracture Sales Representatives and their EBI Trauma Distributors on 3/16/2005.
These devices are distributed nationwide to sales representatives who provide the product directly to the hospital/physician at the time of the surgery. The product was also distributed to Italy and Spain. There are no government accounts.
제품 설명
EBI Ball Tip Guide Wire 3.2mm x 55cm found in the Ankle Arthrodesis Nail Instr., Part Number 469055.