Z-0192-2027

Think Surgical Square Driver REF: 109126

Name: Z-0192-2027 Think Surgical Square Driver REF: 109126
Creator: Think Surgical, Inc.
Published: 2026-08-20
License: https://open.fda.gov/license/

Think Surgical, Inc. / initiated 2026-08-20 / Open, Classified

FDA source

Recall record

Recall number: Z-0192-2027
Status: Open, Classified
Initiated: 2026-08-20
Posted: 2026-10-16
Recalling firm: Think Surgical, Inc.
Product: Think Surgical Square Driver REF: 109126
Product code: OLO Orthopedic Stereotaxic Instrument
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.
FDA 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 notification., 3. Fill out the accompanying Acknowledgement Form. Email the completed Acknowledgement Form to THINK Surgical, Inc at [email protected].
Quantity in commerce: 15 units
Distribution: US Nationwide distribution in the states of NY and DE.
Product codes and lots: Lot: 25356/Primary DI: M9461091260

Product code OLO

K261024Class IITMINI Miniature Robotic SystemTHINK Surgical, Inc. / cleared 2026-07-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-10-21. View this recall on fda.gov (opens on fda.gov)