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Recall Observatory FDA recall evidence

Device product

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

Z-1318-2024

February 12, 2024

Class II

Product summary

Firm
Think Surgical, Inc.
Event
Event 94086
Status
Ongoing
Classification
Class II
Quantity
16
Official record key
device-enforcement:Z-1318-2024

Official wording

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.

Code information: UDI-DI: M9461091010. Lot Numbers: 2316701, 2232601, 23030, 2228501, 2327802, 22152

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.