Recall Z-2716-2026— Think Surgical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Think Surgical, Inc., initiated 2026-05-08. It names one FDA 510(k) clearance: K260010. Product: 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. Reason: Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array..
- Recalling firm
- Think Surgical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-05-08
- Firm location
- Fremont, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
Data sourced from openFDA. This site is unofficial and independent of the FDA.