Recall
Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
Zimmer CAS · 19 April 2015
- Status
- Recall terminated
- Why, in the FDA's words
- “Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use.”
- Recall began
- 19 April 2015
- Company
- 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.