Think Surgical, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1318-2024)
See the recall detail below. You can also see other recalls from the same firm in 2024.
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
Class II
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.
UDI-DI: M9461091010. Lot Numbers: 2316701, 2232601, 23030, 2228501, 2327802, 22152
US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO.
Voluntary: Firm initiated
