Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16641 |
| Brand Name: | Synthes SynFix-LR Implant Holder |
| Model: | Part Number 03.802.039 |
| Affected: | All lots |
| 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: | Complaints have been received which describe the SynFix-LR implant holder breaking at the interface between the implant and holder. If an un-retrieved device fragment remains threaded into the plate, it will not be possible to properly attach the SynFix-LR Aiming Device to the implant (plate). Proper attachment of the Aiming Device to the plate is required for accurate insertion of the four SynFix-LR screws into the SynFix-LR implant (plate) and vertebral bodies. If the tip of the holder should break, the potential exists for an un-retrieved device fragment (URDF) to be left in the SynFix-LR Implant. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 6/5/2014 |
