FDA Device recall Z-0044-2025
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
- FDA Device
- Class II
- ongoing
- Published 2024-10-16
On 2024-10-16 the FDA classified a Class II recall of MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 by Howmedica Osteonics, citing stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0044-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-07 |
| Published | 2024-10-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Howmedica Osteonics |
| Distribution | US |
Product
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Reason
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
Identifiers
| code_info | GTIN: 00848486030193; Serial Numbers: 4200075 4200134 4200177 4200179 4200191 4200234 4200235 4200251 4200339 4200351 4…GTIN: 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 4200671 4200697 4200709 4200712 4200729 4200734 4200757 4200850 4200856 4200868 4200873 4200898 4200902 4200966 4201034 4209747 4209750 4209781 4209789 4209803 4209821 4209864 4209866 4209878 4209882 4209899 4209900 4209950 4209955 4209967 4210004 4210033 4210039 4210051 4210086 4210092 4210098 4210167 4210211 4210213 4210220 4210265 4210267 4210325 4210329 4210359 4210408 4210418 4210439 4210445 4210455 4210503 4210505 4210509 4210522 4219193 4219267 4219400 4219446 4219535 4219682 4219702 4219881 4220005 4220154 4220230 4220237 4220263 4220451 4220452 4220810 4220836 4221090 4221102 4221103 4221106 4221243 4221268 4221335 4221462 4221471 4221563 4221685 4221808 4222927 4222994 4222995 4222996 4222997 4222998 4222999 4223000 4223001 4223003 4223004 42 |
|---|
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-0044-2025%22
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