Recall Z-0192-2027 ยท OLO Orthopedic Stereotaxic Instrument
Think Surgical, Inc.
Think Surgical Square Driver REF: 109126
| Date | Oct 16, 2026 (initiated Aug 20, 2026) |
| Status | Open, Classified |
| 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 |
| Action | On August 25, 2026, THINK Surgical Inc. issued a Urgent Medical Device Recall Notification to affected consignees via email. Think Surgical sent an updated letter via email on September 22, 2026 to provide additional product information. THINK Surgical ask consignees to take the following actions: 1. Examine your inventory of square drivers for the lot number 25356. Quarantined return any inventory of that lot to THINK Surgical, Inc., 2. If you have distributed or transferred affected devices to other facilities or end users, please promptly notify them and provide a copy of this notificat |
| Quantity | 15 units |
| Distribution | US Nationwide distribution in the states of NY and DE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K261024 | TMINI Miniature Robotic System THINK Surgical, Inc., Jul 24, 2026 |