Device recall
Think Surgical Square Driver REF: 109126
- Recall number
- Z-0192-2027
- Event id
- 99870
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Think Surgical, Inc.
- Report date
- Oct 28, 2026
- Posted
- Oct 16, 2026
- Initiated
- Aug 20, 2026
- Center classification date
- Oct 16, 2026
- Product code
- OLO
- Device type
- Orthopedic Stereotaxic Instrument
- 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.
- Root cause
- Process control
- Quantity
- 15 units
- Code info
- Lot: 25356/Primary DI: M9461091260
- Distribution
- US Nationwide distribution in the states of NY and DE.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K261024
- Location
- Fremont, CA, United States