Think Surgical TMINI Femur and Tibia Tracking Arrays
The TMINI Femur and Tibia Tracking Arrays may loosen at the knob, causing misalignment.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Think Surgical, Inc., of Fremont, California, recalled the TMINI Femur Tracking Array REF 109003 and TMINI Tibia Tracking Array REF 109004 due to a manufacturing/design issue where the knob on the tracking array may loosen, causing potential misalignment of the array.
The TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery, assisting the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for accurate placement of knee implant components.
The recall began May 8, 2026, and was added to the FDA's Enforcement Report on July 9, 2026.
The recall covers 360 devices distributed 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.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare these product details with yours, then check the recall notice for any restrictions.
TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System
Details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of 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, and Washington.
- Event ID
- 99219
- Recall No.
- Z-2716-2026
- Company
- Think Surgical, Inc.Fremont, California
- Hazard
- Device defect
- Quantity recalled
- 360 devices
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
