# FDA recall Z-2716-2026

> **Think Surgical, Inc.** · Class II · device recall initiated 2026-05-08.

## 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

- **Recall number:** Z-2716-2026
- **Recalling firm:** Think Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-08
- **Report date:** 2026-07-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fremont, CA, United States

## Primary source

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

## Citation

> MORVS. FDA recall Z-2716-2026. Retrieved 2026-10-22 from https://api.morvs.ai/recall/Z-2716-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*