FDAClass II · Medical device · Recall Z-2716-2026 · Recalled July 15, 2026

TMINI Femur Tracking Array REF 109003 UDI-DI code recall — Think Surgical, Inc.

Agency report date: July 15, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: TMINI Femur Tracking Array REF 109003 UDI-DI code
Company / brand: Think Surgical
Lot / serial / date codes: Model Number: 109003 UDI-DI code: M9461090030 Model Number: 109004 UDI-DI code: M9461090040
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.

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: TMINI Femur Tracking Array REF 109003 UDI-DI code recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2716-2026
Brand: All Think Surgical recalls
Classification: Class II
Units affected: 360 devices
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

TMINI Femur Tracking Array REF 109003 UDI-DI code recall status

Companies & origin

Recalling firm location: Fremont, CA, United States
Firm address: 47201 Lakeview Blvd, N/A, 94538-6530

Identifying details (verbatim from the notice)

Product codes / lots: Model Number: 109003 UDI-DI code: M9461090030 Model Number: 109004 UDI-DI code: M9461090040
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.
Firm notified the public via: Letter
FDA event ID: 99219
Recall initiated: May 8, 2026
FDA classified: July 9, 2026
FDA report date: July 15, 2026

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Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 13, 2026 at 6:00 PM UTC.

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