Think Surgical, Inc. Recalls

2 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (2)

May 8, 2026
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 instr
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
Class II
February 12, 2024
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array guide has the possibility of binding to the array fixation pins during drilling.
Class II

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