| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00093-1 |
| Product Name/Description |
Beaver 4.0mm Banana Blade
Model Number: 72203307
Various Batch Numbers affected
ARTG Number: 140406 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
A number of customer complaints have been received indicating that during arthroscopic hip surgery the blades are experiencing brittle fracture.
In the event the Instrument breaks, the failure is visually obvious to the user and the broken blade can be retrieved. In a rare instance the device could break and fall into surgical site or joint space, making it difficult to retrieve. This can potentially cause a surgical delay. It has also been reported that in rare cases the broken blade remained in the patient. |
| Recall Action |
Recall |
| Recall Action Instructions |
Smith & Nephew is advising users to immediately discontinue the use of the affected units prior to their quarantine and return. |
| Contact Information |
02 9857 3908 - Smith & Nephew |