| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00378-1 |
| Product Name/Description |
Tensioner (Instrument used for general orthopaedic repairs using implants like cerclage wires, cables and crimps/clamps)
Part Number: 03.311.001
Multiple lot numbers
ARTG Number: 203636 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
There have been reports of the instrument falling apart and/or the K-Wire being trapped inside. The connection between the reaction fork and the main body is connected without a gap and secured with tightening of 23Nm. There may be instruments which have not been tighten with adequate torque. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Synthes is requesting that customers return the affected devices for reworking by the manufacturer. |
| Contact Information |
1800 796 8437 - Synthes Australia Customer Service |