| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00341-1 |
| Product Name/Description |
MatrixORTHOGNATHIC Screws; MatrixMANDIBLE Screws; MatrixMIDFACE; MatrixNEURO Screws (Non-sterile and sterile screws supplied as part of a craniofacial fixation plate kit)
Multiple affected lot numbers and part numbers
ARTG Number: 157706 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
The affected screws are packaged in a "clip" that has a laser etch corresponding to the length of the screw. It has been reported that the etch on the clip does not correspond to the length of the screw. There have been instances in which the screw was longer than the specified etch, as well as the screw being shorter than the specified etch. |
| Recall Action |
Recall |
| Recall Action Instructions |
Synthes is asking users to return affected products. If the screws must be used before replacements arrive, Synthes is asking users to measure them prior to use. |
| Contact Information |
1800 796 8437 - Synthes Australia Customer Service |