Recall
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code: 07350137520593 Reamer Adapter OTD REF…
ORTOMA AB · 28 July 2025
- Status
- Recall open, classified
- Why, in the FDA's words
- “Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.”
- Recall began
- 28 July 2025
- Company
- ORTOMA AB
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
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.