FDAFDA · Food and drugs·Recall number Z-1318-2024
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
Published March 27, 2024 · Recall initiated: February 12, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Think Surgical, Inc.
- Distributor
- US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO.
- Lot
- UDI-DI: M9461091010. Lot Numbers: 2316701, 2232601, 23030, 2228501, 2327802, 22152
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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