Recall
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Howmedica Osteonics Corp. · 7 Aug 2024
- Status
- Recall open, classified
- Why, in the FDA's words
- “Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.”
- Recall began
- 7 Aug 2024
- Company
- Howmedica Osteonics Corp.
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K093425
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.