Recall
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Orthosoft, Inc. dba Zimmer CAS · 7 Jan 2022
- Status
- Recall open, classified
- Why, in the FDA's words
- “The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.”
- Recall began
- 7 Jan 2022
- Company
- Orthosoft, Inc. dba Zimmer CAS
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K110054
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.