Think Surgical, Inc.: 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 ste

Hazard

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

Details from the source

Reason for recall: Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array. Distribution: 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. Quantity: 360 devices Lot/code info: Model Number: 109003 UDI-DI code: M9461090030 Model Number: 109004 UDI-DI code: M9461090040

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.