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MEDICAL DEVICE RECALLMODERATE

TMINI Miniature Robotic System Tracking Arrays

Think Surgical is recalling TMINI Femur and Tibia Tracking Arrays because a loose knob may cause surgical misalignment.

What to do

Stop using the affected tracking arrays immediately and contact Think Surgical for further instructions regarding replacement or repair.

Recalled
Listed
Updated
Recall No.
Z-2716-2026
Agency
FDA
Firm
Think Surgical, Inc.
Recall ID
99219
Status
ONGOING

Recall at a glance

Quantity recalled
360 devices

Why it was recalled

Think Surgical is recalling TMINI Femur and Tibia Tracking Arrays due to a manufacturing and design issue where the knob on the tracking array may loosen. This defect can cause potential misalignment of the array during total knee replacement surgery.

Is mine affected?

This recall covers the product below. If you have it, yours is affected.

TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Device Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-07-10 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification