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

Class II

Recalling firm: Think Surgical, Inc.
Reason for recall: Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
Affected products (lot / model / serial): Model Number: 109003 UDI-DI code: M9461090030 Model Number: 109004 UDI-DI code: M9461090040
Units affected: 360 devices
Distribution pattern: 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.
Firm location: Fremont, CA, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-2716-2026
Recall initiated: May 8, 2026
FDA classification date: July 9, 2026
FDA report date: July 15, 2026
FDA event ID: 99219
Last updated on HTM Vibe: July 23, 2026