Recall
SmartTools Knee System Orthopedic Stereotaxic Instrument
Orthosoft, Inc. dba Zimmer CAS · 20 Feb 2017
- Status
- Recall terminated
- Why, in the FDA's words
- “There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P”
- Recall began
- 20 Feb 2017
- Company
- Orthosoft, Inc. dba Zimmer CAS
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K122326
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.