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.
Stryker has received reports from customers indicating post-operative
fracture of the pin that connects the tulip head to the plate body.
조치
Stryker Spine sent a 'Urgent Medical Device Removal Letter'/'Customer Response Form' to Branch Managers, Agent Principals, Quality Contacts, Hospital OR Risk Managers, OR supervisor on 5/30/2013 via Fed Ex. Inventory should be examined and returned.The attached form should be completed and returned as well.
Stryker Spine sent 'Urgent Medical Device Removal Letters' to Spinal Implant Surgeons on 6/20/2013 via Fed Ex.
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long || 5) Mini. || Allows for positioning directly on the midline keel of the occiput.