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 | Terminated |
| Reason | There is a potential for the cutter head to detach from the cutter shaft. |
| Product | Think Surgical Cutter, Flat, 6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The cutter is used to prepare the bone for the (TKA) Total Knee Arthroplasty. |
| Quantity | 951 |
| Distribution | The devices were distributed to the following US states: NJ, NY, OH, and TX. The devices were also distributed to Korea. |
| Initiated | 2018-03-30 |
| Classified | 2018-08-03 |
| Terminated | 2020-01-24 |
| Recall number | Z-2605-2018 |
| 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-2605-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80091/
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