TMINI Tracking Array knob loosening causing potential array misalignment
Think Surgical is recalling TMINI Femur and Tibia Tracking Arrays used in knee replacement surgery because the knob on the tracking array may loosen, causing potential misalignment of the array.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a surgical guidance system where a mechanical failure (knob loosening) could lead to array misalignment during knee replacement surgery. Misalignment of surgical guidance arrays during joint replacement poses risk of significant surgical error and patient harm, consistent with FDA Class II criteria for recalls with risk of serious injury potential.
Plain-English summary
Think Surgical, Inc. is recalling the TMINI Femur Tracking Array (Model 109003, UDI-DI: M9461090030) and TMINI Tibia Tracking Array (Model 109004, UDI-DI: M9461090040). The TMINI Miniature Robotic System is a stereotaxic instrumentation system used to assist surgeons during total knee replacement (TKA) surgery by providing software-defined spatial boundaries and reference information for accurate placement of knee implant components.
The devices are being recalled due to a manufacturing and design issue where the knob on the tracking array may loosen, causing potential misalignment of the array. Approximately 360 devices have been distributed nationwide in the United States across 23 states: AZ, CA, DE, FL, IA, KS, LA, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, TX, UT, VA, and WA.
If you have received or are using these tracking arrays, contact Think Surgical, Inc. immediately for guidance on device inspection, replacement, or return. Do not use affected devices until you have received further instructions from the manufacturer.
The recalled product
- Product
- 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…
- Manufacturer
- Think Surgical, Inc.
- Affected units
- 360
Distribution
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