United StatesTMINI Femur Tracking Array (REF 109003, UDI‑DI M9461090030) and TMINI Tibia Tracking Array (REF 109004, UDI‑DI M9461090040) used with the TMINI Miniature Robotic System for total knee replacement are affected; they were distributed across multiple U.S. states (360 devices). They were recalled because a knob on the tracking array may loosen, which can cause potential misalignment of the array.
What's being recalled
TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components
Recalling firm: Think Surgical, Inc., Fremont, CA, United States.
How to identify it
Model Number: 109003 UDI-DI code: M9461090030 Model Number: 109004 UDI-DI code: M9461090040
The hazard
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide distribution in the states of AZ, CA, DE, FL, IA, KS, LA, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, TX, UT, VA, and WA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)