Recall
TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement…
Think Surgical, Inc. · 8 May 2026
- Status
- Recall open, classified
- Why, in the FDA's words
- “Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.”
- Recall began
- 8 May 2026
- Company
- Think Surgical, Inc.
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K260010
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.