TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M94610

FDA device recall Z-2716-2026 · posted 2026-07-09 · Open, Classified

Recall details

Recalling firm

Think Surgical, Inc.

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

OLO

Quantity affected

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.

Date initiated

2026-05-08

Date posted

2026-07-09

Location

Fremont, CA

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