Think Surgical Square Driver REF: 109126 recall (Think Surgical, Inc.)
Medical deviceClass IIOngoing
Summary: Think Surgical, Inc. is recalling 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.
What is being recalled
Think Surgical Square Driver REF: 109126
Why
Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of NY and DE. (states named: Delaware, New York)
How to tell if yours is affected
Lot: 25356/Primary DI: M9461091260
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0192-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 20, 2026 |
| Reported | October 28, 2026 |
| Company | Think Surgical, Inc. |
| Company location | Fremont, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 15 units |
More recalls from Think Surgical, Inc. · all medical device recalls · recalls from August 2026