TMINI Miniature Robotic System Tracking Arrays
Think Surgical is recalling TMINI Femur and Tibia Tracking Arrays because a loose knob may cause surgical misalignment.
Stop using the affected tracking arrays immediately and contact Think Surgical for further instructions regarding replacement or repair.
Why it was recalled
Think Surgical is recalling TMINI Femur and Tibia Tracking Arrays due to a manufacturing and design issue where the knob on the tracking array may loosen. This defect can cause potential misalignment of the array during total knee replacement surgery.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
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 (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components
- Recall #
- Z-2716-2026
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-07-10 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification