Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16597 |
| Brand Name: | Synthes Trauma External Fixation System "MR Conditional" |
| Model: | Various |
| Affected: | Various |
| Software version: | |
| Recalling Organisation: | Synthes New Zealand Ltd 507 Mt Wellington Highway Mt Wellington Auckland 1060 |
| Contact Information: | 0800 657 734 |
| Manufacturer: | Synthes GmbH |
| Issue: | Labelling changes have been made to Synthes External Fixation Systems (Small, Medium, Large and DO) related to MR conditions as a result of changes in required testing protocols to designate a product MR Safe, MR Conditional, or MR Unsafe. Metal devices are no longer identified as MR Safe and as a result Synthes Ex-Fix Systems are no longer labelled MR Safe and should be treated as MR Conditional. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 6/5/2014 |
