Type of Product |
Medical Device |
TGA Recall Reference |
RC-2014-RN-00097-1 |
Product Name/Description |
Holding Forceps for SynReam Reaming Rod 2.5 mm (used during surgery to retain an instrument, reduce a fracture, spread an osteotomy, or hold an implant in place)
Lot Numbers: 5923464 and 5923181
ARTG Number: 153950 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
24/01/2014 |
Responsible Entity |
|
Reason/Issue |
The angle of the locking lever of Holding Forceps from the affected lots has the incorrect angle and may not lock, resulting in the forceps inability to retain the desired position once applied. |
Recall Action |
Recall |
Recall Action Instructions |
Synthes is advising users to inspect stock and quarantine any affected products to return to Synthes. |
Contact Information |
02 9855 4620 - Synthes Australia |