Fresh Recalls

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

Notice names this product. Think Surgical’s TMINI Femur Tracking Array REF 109003 UDI-DI code is named in FDA Class II recall Z-2716-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array. Identifying details: Model Number: 109003 UDI-DI code: M9461090030 Model Number: 109004 UDI-DI code: M9461090040. Units affected: 360 devices. Status: Ongoing.

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.

Brand
Think Surgical

Recalls naming this model

FDA Class II · Medical device · July 15, 2026

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

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

Company / brand: Think Surgical recalls

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

Official ID Z-2716-2026 · Official record ↗

See all Think Surgical recalls →

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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.