FDAClass II · Medical device · Recalled July 15, 2026

TMINI Femur Tracking Array REF 109003 UDI-DI code recall — Think Surgical, Inc.

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2716-2026
Brand: Think Surgical
Classification: Class II
Units affected: 360 devices
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

TMINI Femur Tracking Array REF 109003 UDI-DI code

Companies & origin

Recalling firm location: Fremont, CA, United States
Firm address: 47201 Lakeview Blvd, N/A, 94538-6530

Identifying details (verbatim from the notice)

Product codes / lots: 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.
Firm notified the public via: Letter
FDA event ID: 99219
Recall initiated: May 8, 2026
FDA classified: July 9, 2026
FDA report date: July 15, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 10:42 PM UTC.

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