Class II — Think Surgical, Inc.
| Recalling firm | Think Surgical Inc. |
|---|---|
| Registered facility | Think Surgical Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array guide has the possibility of binding to the array fixation pins during drilling. |
| Product | Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System |
| Quantity | 16 |
| Distribution | US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO. |
| Initiated | 2024-02-12 |
| Classified | 2024-03-20 |
| Recall number | Z-1318-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Think Surgical, Inc. (Z-1318-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94086/
Alerts for Think Surgical Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.