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 a complaint from customers relating to a fracture during the use of the specialty audible torque wrench in surgery.
조치
Stryker Spine sent an Urgent Medical Device Removal Notification/Acknowledgement Form dated 10/6/2014 via Fed Ex. The letter identified the affected product, discussed the product description, product issue, potential hazards, risk mitigations, and actions needed. Customers were asked to read the notice thoroughly and make sure that it is understood. Additionally, they are to complete the enclosed acknowledgement form and fax or e-mail it back.
Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. || Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors.