| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00555-1 |
| Product Name/Description |
Synthes Trauma External Fixation System (Small, Medium, Distraction Osteogenesis (DO) Ring and Large)
Multiple part numbers and lot numbers affected
ARTG Numbers: 133919, 133921, 133927, 153950, 155806, 155807, 157068, 183900 & 203638 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
Labelling changes have been made to Synthes External Fixation Systems (Small, Medium, Large and DO) related to MR conditions as a result of changes in the required testing protocols to designate a product MR Safe, MR Conditional, or MR Unsafe. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Synthes is notifying hospitals of the change from 'MR Safe' to 'MR Conditional' for all products affected by this product correction. |
| Contact Information |
02 9855 4620 - Synthes Australia |