BfArM listed an urgent field safety notice for the blunt nitinol K-wire used with the ES2 percutaneous pedicle screw system. The nature of the problem is set out only in the manufacturer's advisory PDF, which we could not open.
- Type
- Safety notice
- Company
- Stryker Spine (US)
- Device
- ES2 Spinal System Nitinol K+-Wire Blunt
- Date
- 22 October 2026
- Jurisdiction
- DE
- Classification
- Urgent FSN (BfArM ref 49141/26)
- Source
- BfArM field safety notices
Read the official notice →Source checked
What to do
Act on the regulator's or manufacturer's own notice; this page is a summary, not an official safety channel. If a device has failed or harmed a patient, see Report a Device Problem for who to tell in your country.