| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00605-1 |
| Product Name/Description |
DCP 2.0, 7 holes, length 37 mm, Stainless Steel, Sterile ( Non-biodegradable orthopaedic fixation plate)
Part Number: 243.570S
Lot Number: 1864934
ARTG Number: 157069 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
3/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
The label on the head text does not match the multilingual text ie, the number of holes is not correctly indicated in the multilingual text in the labelling for one or more of the languages. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to isolate the affected units and return it to Synthes Australia. |
| Contact Information |
02 9855 4625 - Synthes Australia |