Type of Product |
Medical Device |
TGA Recall Reference |
RC-2013-RN-00424-1 |
Product Name/Description |
Cortex Screw 3.5mm, self-tapping, length 60mm, Stainless Steel, sterile (Orthopaedic non-biodegradable bone screw)
Part number: 204.860S
Multiple lot numbers affected
ARTG Number: 157068 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class III |
Recall Action Commencement Date |
9/05/2013 |
Responsible Entity |
|
Reason/Issue |
The length of the screw is erroneously indicated as 55mm in the six languages on the back of the box. In the English short text which is visible on the front of the box, on the sides, on the sterile inner blister and on the patient labels, the screw is correctly described as having a length of 60mm. |
Recall Action |
Recall |
Recall Action Instructions |
Synthes is recalling affected units and replacing it with unaffected lots. |
Contact Information |
1800 796 843 - Synthes Australia Customer Service |