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Class IIOngoing

Think Surgical, Inc. recalls Think Surgical Square Driver REF: 109126

Recall date · record updated Oct 28, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Think Surgical, Inc.
Reason
Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of NY and DE.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99870…

Products

  1. Think Surgical Square Driver REF: 109126

    Codes/lots: Lot: 25356/Primary DI: M9461091260Quantity: 15 unitsRecall no. Z-0192-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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