Spinal FrontiersPowered by NSpineThe MHRA published the manufacturer's field safety notice for NDI passive reflective spheres in its 31 August–4 September list, mirroring the US recall over spheres that may not be reliably tracked by optical navigation cameras. The FSN itself is dated September 2026; the date given here is the end of the MHRA listing week. France's ANSM lists a lot recall of the same spheres (R2626613, 8 Sep 2026).
- Type
- Safety notice
- Company
- Northern Digital (NDI) / Medtronic Navigation
- Device
- NDI Passive Spheres (models 8801071, 8801074, 8801075)
- Date
- 4 September 2026
- Jurisdiction
- UK
- Classification
- FSN (MHRA ref 40709365)
- Source
- MHRA Field Safety Notices list
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.