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U.S. Department of Health and Human Services

Class 2 Device Recall TMINI Miniature Robotic System Square Driver

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 Class 2 Device Recall TMINI Miniature Robotic System Square Driversee related information
Date Initiated by FirmAugust 20, 2026
Date PostedOctober 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0192-2027
Recall Event ID 99870
510(K)NumberK261024 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductThink Surgical Square Driver REF: 109126
Code Information Lot: 25356/Primary DI: M9461091260
FEI Number 3000719653
Recalling Firm/
Manufacturer		 Think Surgical, Inc.
47201 Lakeview Blvd
Fremont CA 94538-6530
For Additional Information ContactJonathan Gibson
001-734-8341931
Manufacturer 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 Determined
Cause 2		Process control
ActionOn 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 productreturns@thinksurgical.com.
Quantity in Commerce15 units
DistributionUS Nationwide distribution in the states of NY and DE.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OLO
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