FDA-Device2024-03-27Class II
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
Think Surgical, Inc.
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.
Sold states
US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO.
Affected count
16
Manufactured in
47201 Lakeview Blvd, Fremont, CA, United States
Products
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1318-2024Don't want to check this manually?
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