Think Surgical, Inc. recalls TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking…

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-2716-2026
• FDA 510(k) clearance · K260010The device's official FDA premarket clearance record
• FDA device classification · OLOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.4560The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Think Surgical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.