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

Hazard

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.

Details from the source

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. Distribution: US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO. Quantity: 16 Lot/code info: UDI-DI: M9461091010. Lot Numbers: 2316701, 2232601, 23030, 2228501, 2327802, 22152

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.