NDI Passive Sphere™ – Model No. 8801071, 8801074, 8801075 & Medtronic Biopsy Needle Kit – Model No. 9733068

Brief description of the problem (reason for recall)

The purpose of this letter is to advise customers that Medtronic is recalling specific lots of Northern Digital Inc (NDI) Passive Sphere and Medtronic Biopsy Needle Kits due to variability in the sphere reflective coating which may impact the Medtronic optical navigation or robotic guidance systems, including the Stealth AXiS™ Surgical System, StealthStation™ S8 System, StealthStation™ S7 Surgical Navigation System, Stealth Autoguide™ Robotic Guidance System and Mazor X™ robotic guidance system.

NDI passive spheres are single-use devices that attach to passive tracking instrument posts and are used during optical navigation procedures. The sphere manufacturer (NDI) 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.

Advice for health professionals and distributors:

Customer Actions:

Medtronic requests that you take the following actions:

• Immediately locate and quarantine all unused impacted product(s). See Attachment A for affected Medtronic lot numbers.
• Return unused impacted product(s) to Medtronic following the instructions in the enclosed Customer Acknowledgment Form.
• Complete the Customer Acknowledgment Form enclosed with this letter, acknowledging that you have received this information, and email the completed form to Medtronic.

– If the affected devices have already been utilized and/or discarded, we still ask that you complete and return the Customer Acknowledgment Form detailing that information.

• This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records.

Additional Information:

If you purchase this product directly from NDI, please contact NDI for the list of impacted product and instructions for return: spheres-na@ndigital.com

Medtronic has notified the Competent Authority of your country of this action.

We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic Sales Representative.

We appreciate your immediate attention and cooperation.

Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points, and the recall process was initiated.

Reporting side effects

Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.