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.
The inner shaft does not extend far enough from the tip of the revision screwdriver to fully engage the bone screw.
조치
URGENT PRODUCT RECALL letters were sent to all branches/agencies who received the product on June 5, 2008.
If you have questions, contact Michelle Klein at 201-760-8256.
The product was distributed to 13 Stryker branches/agencies.
제품 설명
Reflex Revision Screwdriver Inner Shaft is a orthopedic manual surgical instrument that is a nonpowered, hand held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. Ref Number 48500900;Non Sterile