Recall
Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device.
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) · 24 Sept 2020
- Status
- Recall open, classified
- Why, in the FDA's words
- “System does not include a drill guide.”
- Recall began
- 24 Sept 2020
- Company
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K200095
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.