Class 2 Device Recall TMINI Tracking Arrays (Femur and Tibia)

• Date Initiated by Firm: May 08, 2026
• Date Posted: July 09, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2716-2026
• Recall Event ID: 99219
• 510(K)Number: K260010
• Product Classification: Orthopedic stereotaxic instrument - Product Code OLO
• 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
• Code Information: Model Number: 109003 UDI-DI code: M9461090030 Model Number: 109004 UDI-DI code: M9461090040
• FEI Number: 3000719653
• Recalling Firm/ Manufacturer: Think Surgical, Inc.; 47201 Lakeview Blvd; Fremont CA 94538-6530
• For Additional Information Contact: Jonathan Gibson; 734-834-1931
• Manufacturer Reason for Recall: Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OLO