Recall Z-2716-2026 · OLO Orthopedic Stereotaxic Instrument
Think Surgical, Inc.
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
| Date | Jul 9, 2026 (initiated May 8, 2026) |
| Status | Open, Classified |
| Reason | Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array. |
| Root cause | Process control |
| Action | A "MEDICAL DEVICE RECALL" Letter was emailed to customers informing them that THINK Surgical Incorporated is voluntarily notifying you of a potential defect in its Tracking Arrays (Femur and Tibia). THINK Surgical Incorporated has become aware that the tracking arrays may become loose. There have been 11 complaints regarding loose tracking arrays. if a Tracking Array is loose and moves when attached to the Tracking Array Bracket, it could result in incorrect positional information communicated to the system, potentially impacting system accuracy. Customers are instructed to: Prior to each us |
| Quantity | 360 devices |
| Distribution | U.S. Nationwide distribution in the states of AZ, CA, DE, FL, IA, KS, LA, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, TX, UT, VA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K260010 | TMINI® Miniature Robotic System THINK Surgical, Inc., Mar 3, 2026 |