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Home › FDA recalls › Think Surgical Square Driver REF: 109126
CLASS II · ModerateFDA

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

📅 Aug 20, 2026 · 📍 Nationwide
Recalling company
Think Surgical, Inc.
Product
Think Surgical Square Driver REF: 109126
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Aug 20, 2026
Reported
Oct 28, 2026
Distribution
US Nationwide distribution in the states of NY and DE.
Status
Ongoing
Quantity
15 units
Lot / codes
Lot: 25356/Primary DI: M9461091260
Company location
Fremont, CA
Recall type
Voluntary: Firm initiated
Recall number
Z-0192-2027
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0192-2027 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.