FDA Medical devices recall · July 15, 2026

TMINI Femur Tracking Array recall

Read the official FDA notice ↗

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

Why was it recalled?

Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Model Number: 109003 UDI-DI code: M9461090030 Model Number: 109004 UDI-DI code: M9461090040

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.

States: 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

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-2716-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.