FDA Device recall Z-1914-2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1…
- FDA Device
- Class II
- ongoing
- Published 2024-06-05
On 2024-06-05 the FDA classified a Class II recall of Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1… by Stryker Orthopaedics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1914-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-15 |
| Published | 2024-06-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Stryker Orthopaedics |
| Distribution | US |
Product
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.de.1+TKA 1.0.1.de.1+PKA3.0.2.de. Application Part Number: 700002190743-03
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
Identifiers
| code_info | UDI-DI: (01)07613327629132(10). Software: TKA 2.0.de.1+TKA 1.0.1.de.1+PKA3.0.2.de. Application Part Number: 700002190743-03. Revision: AA, AB, AC, & AD. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1914-2024%22
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