Class II Recall

TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M

Summary

The FDA issued a Class II for TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia T by Think Surgical, Inc.. Reason: Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array..

Details

Source

Device Recall

External ID

Z-2716-2026

Action Date

2026-07-15

Status

Ongoing

Product 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

Lot/Code Info: Model Number: 109003 UDI-DI code: M9461090030 Model Number: 109004 UDI-DI code: M9461090040

Quantity Affected: 360 devices

Reason for Recall

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

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-05-08

Company

Think Surgical, Inc.

Fremont, CA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 143 device recalls issued in the same week, part of 452 device-related FDA actions this month.

Think Surgical, Inc. has 11 FDA actions in our database, including 2 recalls and 9 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Think Surgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Think Surgical, Inc. have FDA actions?

Think Surgical, Inc. has 11 FDA actions in our database, including 2 recalls and 9 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2716-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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