| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00729-1 |
| Product Name/Description |
The Mako Integrated Cutting System (MICS)
Catalogue Number: 209063
GTIN:00848486030193
Multiple Serial Numbers
ARTG 223107
(Stryker Australia Pty Ltd - Surgical procedure kit, orthopaedic, reusable) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has identified a problem with the characterisation process that impacted the constant values assigned to the associated MICS Handpieces.
The MICS constants are used by the Mako robot to position the MICS cutting tools according to the surgical plan. As a result, the physical Tool Center Point (TCP) does not match the value expected by the Mako System software.
This problem may result in a failed Mako Registration and Verification and/or an unsuccessful cutting tool check.
The problem may also cause a discrepancy during bone preparation in a Mako Total Knee or a Mako Partial Knee procedure. The surgeon may make cuts during bone preparation that differ from the surgeon’s preoperative plan. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to:
- Quarantine any affected product and discontinue use.
- Contact their local Stryker representative to coordinate the return and replacement of any affected product.
Patients treated with an affected product identified should continue to be followed per the normal protocol established by their surgeon(s). There are no recommended changes to the frequency of the standard follow-up care protocol. |
| Contact Information |
0439 661 638 - postmarketssp@stryker.com - Stryker South Pacific |