Total Knee Arthroplasty — Class II medical device recall Z-1910-2024
Ongoing recall by Stryker Orthopaedics, reported 2024-06-05, distributed nationwide. Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999
| Recall number | Z-1910-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Orthopaedics, Montclair, NJ, United States |
| Recall initiated | 2024-04-15 |
| Classified | 2024-05-28 |
| Reported by FDA | 2024-06-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CL, CN, DE, DK, ES, FI, FR, GB, GR, IL, IN, IT, JP, KR, KW, LU, MX, MY, NL, NZ, QA, RO, SA, SE, SG, TH, TR, ZA |
| Quantity | 334 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07613327566468 |
| Model numbers | 700001590415 |
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 + TKA 1.0.1 + THA 4.0.0.1 + PKA 3.0.2 Application Part Number: 700001590415
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1910-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.