Think Surgical, Inc. recalls TMINI Femur Tracking Array REF 109003

Recalling company

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

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

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

May 8, 2026

Reported

Jul 15, 2026

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.

Status

Ongoing

Quantity

360 devices

Lot / codes

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

Company location

Fremont, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-2716-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2716-2026 in the FDA Enforcement Report. Also see FDA recall press releases.