Think Surgical, Inc.: TMINI Array Guide Recalled for Risk of Binding During Drilling

Agency Publication Date: March 20, 2024

Summary

Think Surgical, Inc. has recalled 16 units of the TMINI Array Guide Assembly (REF: 109101), which is a component of the TMINI Knee Instrument Set used in robotic knee surgeries. The recall was initiated because the guide holes in the assembly may be too narrow, causing friction and a "cold-weld" effect with the fixation pins during surgical drilling. This defect can cause the array guide to bind to the pins while the surgeon is operating. These devices were distributed across several states including Alabama, California, Missouri, Nevada, Ohio, Texas, and Utah.

Risk

The friction between the pins and the guide holes can cause the components to seize or bind together during surgery. This may lead to surgical delays, potential inaccuracies in the robotic system's alignment, or the need for additional medical intervention to safely separate the bound components.

What You Should Do

Identify if your facility has the affected TMINI Array Guide Assembly (REF: 109101) by checking the lot numbers on the device packaging or hospital inventory records.
Locate the specific affected lot numbers: 2316701, 2232601, 23030, 2228501, 2327802, or 22152.
Check for the Unique Device Identifier (UDI-DI) M9461091010 to confirm the product identity.
Immediately stop using any units from the affected lots and sequester them to prevent further use in surgical procedures.
Contact Think Surgical, Inc. directly at their Fremont, California headquarters to arrange for the return or replacement of the affected instruments.
Contact your healthcare provider if you have concerns regarding a recent surgery where this robotic system was utilized.
For additional information or technical questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification and Device Correction

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Assembly, Array Guide TMINI, REF: 109101

Model / REF:

REF: 109101

UDI-DI: M9461091010

Lot Numbers:

2316701

2232601

23030

2228501

2327802

22152

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94086

Status: Active

Manufacturer: Think Surgical, Inc.

Sold By: Specialized surgical centers; Hospitals

Manufactured In: United States

Units Affected: 16

Distributed To: Alabama, Ohio, Nevada, Texas, Utah, California, Missouri

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if your facility has the affected TMINI Array Guide Assembly (REF: 109101) by checking the lot numbers on the device packaging or hospital inventory records.

Locate the specific affected lot numbers: 2316701, 2232601, 23030, 2228501, 2327802, or 22152.

Check for the Unique Device Identifier (UDI-DI) M9461091010 to confirm the product identity.

Immediately stop using any units from the affected lots and sequester them to prevent further use in surgical procedures.

Contact Think Surgical, Inc. directly at their Fremont, California headquarters to arrange for the return or replacement of the affected instruments.

Contact your healthcare provider if you have concerns regarding a recent surgery where this robotic system was utilized.

For additional information or technical questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.