FDA recall, , Moderate risk
Think Surgical Square Driver
The Think Surgical Square Driver failed design specifications, potentially causing a pin to stick or wobble during drilling.
Summary by Recall Canary from the FDA notice
What happened
Think Surgical, Inc. is recalling the Think Surgical Square Driver REF: 109126 because the robotic system square drive failed to meet design specifications, potentially resulting in the pin becoming stuck in the square driver or the pin wobbling during drilling. The recall involves 15 units and was initiated on August 20, 2026.
The product was distributed nationwide in the states of New York and Delaware. The FDA added the recall to its Enforcement Report on October 16, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its lot code is listed.
Think Surgical Square Driver REF: 109126
- Lot code
- 25356
- M9461091260
Recall details
- Company began the recall
- Company
- Think Surgical, Inc.
- Hazard
- Quality testing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99870
- Recall number
- Z-0192-2027
- Quantity recalled
- 15 units
All recalls from Think Surgical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary