| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00574-1 |
| Product Name/Description |
SERFAS 90° Energy Probe (90R Probe)
(Electrosurgical system electrode)
Item Number: 279-350-101
Affected Lots: 13128AE2 to 14337AE2
ARTG Number: 146512 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has been made aware of a spike in the occurrence of tip breaks identified for the 90R Probe. The investigation triggered by same confirmed the shape and location of the tip break in each case to be the same. In each event a small piece from the distal end of the alumina ceramic broke off. The geometry of this type of crack differs from those normally observed by SERFAS probes. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to check any SERFAS 90° Energy Probe items in their possession and quarantine any affected units immediately . A Stryker Representative will coordinate an inspection of your affected items in quarantine. Any affected items will be removed by the Stryker Representative and a credit will be issued. This action has been closed-out on 08/08/2016. |
| Contact Information |
1800 803 601 - RAQA Coordinator |