Recall
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Mako Surgical Corporation · 9 July 2020
- Status
- Recall terminated
- Why, in the FDA's words
- “Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.”
- Recall began
- 9 July 2020
- Company
- Mako Surgical Corporation
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K141989
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.