Recall Z-1318-2024— Think Surgical, Inc.

Name: FDA recall Z-1318-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-12

Class II · Ongoing

Class II FDA medical device recall by Think Surgical, Inc., initiated 2024-02-12. It names one FDA 510(k) clearance: K230202. Product: Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System. Reason: 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..

Recalling firm: Think Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-02-12
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K230202 — TMINI Miniature Robotic SystemTHINK Surgical, Inc.·cleared 2023-04-25

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

Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System

Reason for recall

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.

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