- Recalling firm
- Think Surgical, Inc.
- Reason for recall
- Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.
- Affected products (lot / model / serial)
- Lot: 25356/Primary DI: M9461091260
- Units affected
- 15 units
- Distribution pattern
- US Nationwide distribution in the states of NY and DE.
- Firm location
- Fremont, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0192-2027
- Recall initiated
- August 20, 2026
- FDA classification date
- October 16, 2026
- FDA report date
- October 28, 2026
- FDA event ID
- 99870
- Last updated on HTM Vibe
- November 3, 2026
