Medical Device Recall: Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
Think Surgical, Inc. · February 12, 2024
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.
States Affected
NATIONWIDE
Quantity Affected
16
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1318-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.