| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00452-1 |
| Product Name/Description |
Cochlear Baha Soft Tissue Gauge (included in the Cochlear Baha Attract surgical tool kit)
Part Number: 95070
ARTG Number: 205705 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
The Cochlear Baha Soft Tissue Gauge, Part #95070 may have a manufacturing imperfection in the smooth surface of the metal. While this imperfection is minimal, Cochlear's risk analysis has indicated that it could potentially leave residual metal on the patient’s skin. To date there have been no adverse events reported to Cochlear associated with the use of this instrument. |
| Recall Action |
Recall |
| Recall Action Instructions |
Cochlear will remove and replace current Soft Tissue Gauge with an unaffected instrument as quickly as possible. This new instrument has passed additional inspection under microscope to ensure it is not affected by this issue. The instruments removed from the field will also be subjected to the additional inspection under microscope and, if unaffected, be returned for use as required. Any instruments failing additional inspection under microscope will be scrapped.
There is no change to clinical management guidelines for patients who have had implant surgery using this instrument. |
| Contact Information |
02 9428 6555 - Cochlear Limited |