TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia... recall (Think Surgical, Inc.)
Medical deviceClass IIOngoing
Summary: Think Surgical, Inc. is recalling 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. Reason: Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
What is being recalled
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
Why
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: Arizona, California, Delaware, Florida, Iowa, Kansas, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington)
How to tell if yours is affected
Model Number: 109003 UDI-DI code: M9461090030 Model Number: 109004 UDI-DI code: M9461090040
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2716-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 8, 2026 |
| Reported | July 15, 2026 |
| Company | Think Surgical, Inc. |
| Company location | Fremont, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 360 devices |
More recalls from Think Surgical, Inc. · all medical device recalls · recalls from May 2026