Official recall notice
FDA DeviceClass IINotable
FDA Recall: TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 10
- Recall date
- 2026-07-15
- Brand
- Think Surgical, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
Product description
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
Affected products
Model Number: 109003 UDI-DI code: M9461090030 Model Number: 109004 UDI-DI code: M9461090040