Recall Z-0192-2027— Think Surgical, Inc.

Name: FDA recall Z-0192-2027
Creator: U.S. Food and Drug Administration
Published: 2026-08-20

Class II · Ongoing

Class II FDA medical device recall by Think Surgical, Inc., initiated 2026-08-20. It names one FDA 510(k) clearance: K261024. Product: Think Surgical Square Driver REF: 109126. Reason: Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling..

Recalling firm: Think Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-08-20
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K261024 — TMINI Miniature Robotic SystemTHINK Surgical, Inc.·cleared 2026-07-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Think Surgical Square Driver REF: 109126

Reason for recall

Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.

Data sourced from openFDA. This site is unofficial and independent of the FDA.