Think Surgical Cutter — Class II medical device recall Z-2605-2018
Terminated recall by Think Surgical, Inc., reported 2018-08-15, distributed in NJ, NY, OH, TX. There is a potential for the cutter head to detach from the cutter shaft.
| Recall number | Z-2605-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Think Surgical, Inc., Fremont, CA, United States |
| Recall initiated | 2018-03-30 |
| Classified | 2018-08-03 |
| Reported by FDA | 2018-08-15 |
| Terminated | 2020-01-24 |
| Distributed | NJ, NY, OH, TX |
| Countries outside the US | KR |
| Quantity | 951 |
| Reason classes | device malfunction |
| Lot numbers | 100496, 10201, 10313, 1626303, 9158, 9209, 9230, 9269, 9287, 9288, 9519, 9563, 9642, 9834, 9855, 9869, 9890 |
| Model numbers | 106428 |
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.
Reason for recall
There is a potential for the cutter head to detach from the cutter shaft.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2605-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.