Reported Mar 27, 2024 · Ongoing
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic…
Think Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Think Surgical, Inc. · 47201 Lakeview Blvd · Fremont, CA · 94538-6530
Is this the product you have?
- Assembly, Array Guide TMINI
- REF109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
- Lot codes and dates
- UDI-DIM9461091010
- Lot Numbers
23167012232601230302228501232780222152
- Amount recalled
- 16
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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