Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20429 |
| Brand Name: | Trigen Internal Hex Captured Recon screws Blue 6.4 mm x 65mm |
| Model: | Intramedullary Nail System IFU |
| Affected: | 71642365 |
| Software version: | |
| Recalling Organisation: | Smith & Nephew Surgical Ltd Unit A 36 Hillside road Wairau Valley AUCKLAND 0760 |
| Contact Information: | 0800 657 799 |
| Manufacturer: | Smith & Nephew Inc |
| Issue: | Several lots of TRIGEN® INTERNAL HEX CAPTURED RECON SCREW BLUE 6.4MM x 65MM, Model # 71642365 were supplied with incorrect Instructions for Use (IFU). The Fracture Fixation IFU (Reference # 81078017) was packaged with the device instead of the correct Intramedullary Nail System IFU (Reference #) 81090283. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/7/2016 |
