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 | Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array. |
| Product | TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components |
| Quantity | 360 devices |
| Distribution | U.S. Nationwide distribution in the states of AZ, CA, DE, FL, IA, KS, LA, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, TX, UT, VA, and WA. |
| Initiated | 2026-05-08 |
| Classified | 2026-07-09 |
| Recall number | Z-2716-2026 |
| 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-2716-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99219/
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