Z-2716-2026 Class II Ongoing
FDA device recall Z-2716-2026 was initiated by Think Surgical, Inc. on May 8, 2026 and is designated Class II. Reason for recall: Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array. The recall status is ongoing. Affected quantity: 360 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2026
- Initiation Date
- May 8, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 360 devices
Product Description
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 surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components
Reason for Recall
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
Distribution Pattern
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.
Code Information
Model Number: 109003 UDI-DI code: M9461090030 Model Number: 109004 UDI-DI code: M9461090040