Think Surgical, Inc.: 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

Recall number

Z-2716-2026

Recalling firm

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

Status

Open, Classified

Initiated

2026-05-08

Posted

2026-07-09

Terminated

not on file

Reason

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

Root cause

Process control

Action

A "MEDICAL DEVICE RECALL" Letter was emailed to customers informing them that THINK Surgical Incorporated is voluntarily notifying you of a potential defect in its Tracking Arrays (Femur and Tibia). THINK Surgical Incorporated has become aware that the tracking arrays may become loose. There have been 11 complaints regarding loose tracking arrays. if a Tracking Array is loose and moves when attached to the Tracking Array Bracket, it could result in incorrect positional information communicated to the system, potentially impacting system accuracy. Customers are instructed to: Prior to each use of any tracking array, the user should confirm that the tracking array is rigidly fixed in place and not loose when attached to the tracking array bracket. If the tracking array is loose, please use a replacement tracking array. -Fill out the accompanying Acknowledgement Form. Email the completed Acknowledgement Form to THINK Surgical, Inc at productreturns@thinksurgical.com. - Examine their inventory of tracking arrays and inspect them before each use. Please see Appendix 1 attached for instructions to perform the inspection method. - THINK Surgical Incorporated will provide customers with a Returned Material Authorization Form (RMA), a FedEx Envelope and return Fedex AirBill to return any affected devices. Customers will receive replacement unit(s). For Questions - Contact THINK Surgical Incorporated Customer Service at phone 833-878-4465 or customerservice@thinksurgical.com.

Quantity

360 devices

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.

Lot, serial or model codes

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

510(k) numbers

K260010

PMA numbers

not on file

Product code

OLO

Firm FEI

3000719653

Firm city

Fremont

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06

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