MAKO Integrated Cutting System — Class II medical device recall Z-0044-2025
Ongoing recall by Howmedica Osteonics Corp., reported 2024-10-16, distributed nationwide. Stryker has identified an issue with the characterization process that impacted the constant values assigned t
| Recall number | Z-0044-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2024-08-07 |
| Classified | 2024-10-09 |
| Reported by FDA | 2024-10-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, DE |
| Quantity | 897 units |
| UPC / GTIN / UDI-DI | 00848486030193 |
| Serial numbers | 4200075, 4200134, 4200177, 4200179, 4200191, 4200234, 4200235, 4200251, 4200339, 4200351, 4200359, 4200387, 4200427, 4200461, 4200510, 4200515, 4200531, 4200602, 4200608, 4200611, 4200639, 4200641, 4200648, 4200650, 4200653 and 475 more |
| Model numbers | 209063 |
Product
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Reason for recall
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
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-0044-2025. 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.