Think Surgical, Inc. recalls Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic…

Recall date

February 12, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1318-2024

FDA classification

Class II

Brand / firm

Think Surgical, Inc.

Sold / distributed

US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO.

Why it was recalled

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 means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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