Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28912 |
| Brand Name: | Nuvasive PRECICE System |
| Model: | |
| Affected: | Multiple Item numbers |
| Software version: | |
| Recalling Organisation: | Lifehealthcare Ltd New Zealand Unit E 61 Hugo Johnston Drive Penrose Auckland 1642 |
| Contact Information: | |
| Manufacturer: | Nuvasive Specialized Orthopaedics Inc |
| Issue: | The manufacturer is advising that additional biological assessments (carcinogenicity, chronic toxicity, developmental toxicity, and reproductive toxicity) have now been completed and the IFU for Precice Unyte, Precice Freedom trade names have been updated to include: · Clarification that the device is intended for use only in adults · Warning that no more than two (2) devices should be implanted at a time · Patients should weigh 50 lbs or more while undergoing treatment with the devices listed |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 1/2/2022 |
