Recall

Think Surgical, Inc.: TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniatur Recall

Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array. Product details: 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...

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Agency
FDA
Record ID
Z-2716-2026
Canonical
https://claimwatch-mvp.vercel.app/item/think-surgical-inc-tmini-femur-tracking-array-ref-109003-udi-di-code-m9461090030-tmini-tib/

What happened?

Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array. Product details: 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...

Who may be affected?

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.

What should consumers do?

Affected quantity: 360 devices

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No. This page is informational. Always confirm eligibility, deadlines, and safety instructions through official sources.

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