Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19094 |
| Brand Name: | Brainlab Disposable Reflective Marker Spheres (DRMS) |
| Model: | 41773G, 41774G, 41772G |
| Affected: | 1014213001, C103461502, C107761402, C100111501, C1034813001, C108341301, C101021502, C103881402, C108721402, C101161401, C104761402, C109051301, C101611502, C105541402, C109251402, C102311401, C106521402, C1098312001, C102481502, C106721301, C110411401 |
| Software version: | |
| Recalling Organisation: | Johnson & Johnson (NZ) Limited 13a Gabador Place Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 922 638 |
| Manufacturer: | Northern Digital Inc |
| Issue: | Some DRMS may separate at the mid-point where the two halves of the sphere are sealed together. Separation may occur during installation of the spheres onto reference arrays or surgical tools (i.e., when threading them onto posts), or potentially after installation on tools that are impacted with high forces. Should such a DRMS separate during a surgical procedure, there is a possibility for: - A portion of the sphere, its reflective coating and cured or uncured adhesive contacting patient tissues. - Contamination of surgical trays, surgical drapes, surgical tools or physicians' gloves due to contact with the separated component. - Prolongation of surgery due to the need to replace the broken sphere. The resulting separated sphere halves will not continue to be tracked by the Brainlab Image Guided Surgery system. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 9/11/2015 |
