Think Surgical, Inc.: TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI

Company / brand

Think Surgical, Inc.

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 / hazard

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

Classification

Class II

Status

Ongoing

Distribution / sold at

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.

Recall initiated

2026-05-08

Code info

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

Product quantity

360 devices

Voluntary mandated

Voluntary: Firm initiated

City

Fremont

State

CA

Country

United States

Event id

99219

Get the daily digest, and tell us what to watch. Everything is optional except your email.