Think Surgical, Inc.: Orthopedic Stereotaxic Instrument
Recall Summary Think Surgical is recalling its Square Driver orthopedic surgical instrument (model 109126) because the robotic system component may not work as designed, potentially causing a surgical pin to become stuck or move unstably during drilling procedures. The product was distributed nationwide across all U.S. states and Washington, D.C. This is a Class II recall, indicating a potential serious health issue.
- Recalling firm
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-20
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of NY and DE.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/deb0d785-b88f-4c10-998f-2d264f9bf94e