Reported Jul 15, 2026 · Ongoing · Updated Sep 16, 2026
TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code:…
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?
3 of 3 products
| Model / number | Product as published |
|---|---|
109003 | UDI-DI code: M9461090030 TMINI Tibia Tracking Array |
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 |
- Lot codes and dates
- Model Number109003
- UDI-DI codeM9461090030
- Model Number109004
- UDI-DI codeM9461090040
- Amount recalled
- 360 devices
Where it was sold
Why it was recalled
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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