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Think Surgical, Inc. recalls Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic S
Recalled March 27, 2024 · FDA recall Z-1318-2024 · Think Surgical
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. · FDA Class II
Units
16
Sold at
US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO.
Description
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.
Product
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
Manufacturer(s)
Think Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →