Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21695 |
| Brand Name: | Patient Reference Frame ( Unclassified) |
| Model: | |
| Affected: | 9734715 Spinous Process Clamp, Tall, 9734716 Spinous Process Clamp, Short, 9734723 Double Spinous Process Clamp, Tall, 9734724 Double Spinous Process Clamp, Short, 9734715K Spinous Process Clamp, Tall, 9734716K Spinous Process Clamp, Short and 9734723K |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Medtronic Navigation Inc |
| Issue: | The manufacturer has become aware of instances where Spine Clamps have been damaged when forced open beyond their intended limits during use and will subsequently not open once attached to a patient's spinous process. When the Spine Clamp is forced open beyond its intended limits, a component (captive washer) may break off. The washer could then be inadvertently left behind in a patient's body if the breakage occurs during the procedure. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/7/2017 |
