FDA-Device2026-10-16Class IIPROCESSING DEFECT
Think Surgical Square Driver recalled for design defect risk during drilling
What this means
Think Surgical's Square Driver robotic component did not meet design specifications. This could cause the pin to become stuck or wobble during surgical drilling procedures. No injuries have been reported.
- If you use this device, contact Think Surgical for guidance or a replacement
- Do not use the affected unit (Lot 25356, DI M9461091260) until you receive instructions from the manufacturer
The agency's original wording
Hazard
Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of NY and DE.
Affected count
15 units
Manufactured in
47201 Lakeview Blvd, Fremont, California, United States
Products
Think Surgical Square Driver
REF: 109126
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0192-2027Want us to check the next one for you?
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