FDA recall Z-2716-2026

Think Surgical, Inc. · Class II · device

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 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

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.

Key facts

Status: Ongoing
Initiation date: 2026-05-08
Report date: 2026-07-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Fremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2716-2026