Recall
Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN…
Medtronic Navigation, Inc. · 6 Dec 2018
- Status
- Recall terminated
- Why, in the FDA's words
- “Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and not return to its original position, even when connections are tight and secure.”
- Recall began
- 6 Dec 2018
- Company
- Medtronic Navigation, Inc.
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K131425
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.