Spinal FrontiersPowered by NSpineVariation in the reflective coating may stop the navigation camera detecting and tracking the spheres; more than 14,000 units were distributed in the US and abroad. Unused stock is to be quarantined and returned; the root cause is still under investigation.
- Type
- Recall
- Company
- Medtronic Navigation
- Device
- NDI Passive Spheres (REF 8801071, 8801074, 8801075) and passive biopsy needle kit (REF 9733068)
- Date
- 31 August 2026
- Jurisdiction
- US
- Classification
- FDA Class II recall (Z-0194-2027 to Z-0197-2027)
- Source
- FDA Medical Device Recalls database
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.