Stryker Orthopaedics Recall 94473
Description: Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0.it.1+TKA 1.0.1.it.1+PKA3.0.2.it. Application Part Number: 700002190743-01
Stryker Orthopaedics Recall 94473 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1913-2024 |
| Event ID | 94473 |
| Event Description | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0.it.1+TKA 1.0.1.it.1+PKA3.0.2.it. Application Part Number: 700002190743-01 |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide and the countries of Australia, Canada, Chile, China, Columbia, India, Japan, Korea, Malaysia, Mexico, Sweden, Singapore, Thailand, and Netherlands. |
| Quantity | 68 units |
| Recall Reason | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment |
| Device Classification | 20240605 |
| Device Code Info | UDI-DI: (01)07613327629118(10) |
| Center Classification Date | 20240528 |
| Recall Initiation Date | 20240415 |
| Recalling Firm | Stryker Orthopaedics |
| Initial Notification | Letter |
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