| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00857-1 |
| Product Name/Description |
Mako Internal cPCI Card Cage
Item Number: 201337
Lot Number: 05212015
ARTG Number: 223105 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has determined that during assembly of the cPCI Card Cage, a potential cross threading of the 3.3 VDC lug may exist. Visual inspection did not confirm the assembly error. This condition could result in an intermittent power connection in the cPCI Card Cage and abnormal system behaviour or a total loss of power.
Powering down of the system due to intermittent or total loss of power is estimated to have a probability of occurrence at 0.0022%. This would make the system temporarily unavailable. Potential harms resulting in this failure mode are extended surgical time of =15 minutes or extended surgical time of >30 minutes. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Stryker is requesting customers:
1. Inform users of this Recall for Product Correction and forward the notice supplied to all internal staff who need to be aware of this issue;
2. A Stryker representative will coordinate a time for the inspection and, if necessary, replace the cPCI Unit. The Mako may continue to be used in the meantime;
3. Complete the supplied “Recall for Product Correction Notification Response” form to acknowledge you have seen this letter. Return the completed form to Stryker by email to recalls@stryker.com or fax on (02) 9467 1325; and
4. If affected stock could have been transferred from your hospital to another location, please immediately let them know of this recall action.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 9467 1175 - Stryker |