Recall
Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN…
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) · 11 Sept 2020
- Status
- Recall terminated
- Why, in the FDA's words
- “The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.”
- Recall began
- 11 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.