| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00445-1 |
| Product Name/Description |
SynFix-LR Surgical Implant Holder
Part Number: 036.000.915
ARTG Number: 153950 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
Complaints have been received which describe the SynFix LR implant holder breaking at the interface between the implant and holder breaking at the interface between the implant and holder. If an unretrieved device fragment remains threaded into the plate, it will not be possible to properly attach the SynFix Aiming Device to the implant (plate). Proper attachment of the Aiming Device to the plate is required for accurate insertion of the four SynFix screws into the SynFix implant (plate) and vertebral bodies. If the tip of the implant holder should break, the potential exists for an unretrieved device fragment (URDF) to be left in the SynFix-LR Implant. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
DePuy Synthes is updating the SynFix-LR Surgical Technique Guide and notifying their customers that the SynFix Set Case design has been updated to incorporate two additional wrenches to facilitate correct assembly/disassembly and an additional implant holder to facilitate continuation of surgery. Customers are also reminded that an alternative instrument to the implant holder (SQUID, 03.802.121) can be used for the insertion of the implant in suitable cases. |
| Contact Information |
1800 7968 437 (1800 SYNTHES) - Synthes Australia |