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

Recalled July 15, 2026 · FDA recall Z-2716-2026 · Think Surgical

Hazard

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

Units

360 devices

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.

Description

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

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

Manufacturer(s)

Think Surgical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →