Official recall record

NDI Passive Spheres™

What the authority reported

The sphere manufacturer has identified variation in the reflective material used on a limited number of sterile passive sphere lots. The reflective material is the outer coating of the sphere that reflects infrared light from the optical tracking cameras, enabling detection and tracking of instruments during navigation procedures. Medtronic has determined that this variability may affect the ability of the navigation system to detect and track the spheres. Potential impacts may include instrument verification failures, intermittent or lost tracking, red status tracking or navigation accuracy.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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