TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI… — Class II medical device recall Z-2716-2026
Ongoing recall by Think Surgical, Inc., reported 2026-07-15, distributed nationwide. Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignme
| Recall number | Z-2716-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Think Surgical, Inc., Fremont, CA, United States |
| Recall initiated | 2026-05-08 |
| Classified | 2026-07-09 |
| Reported by FDA | 2026-07-15 |
| Distributed | Nationwide (US) |
| Quantity | 360 devices |
| Model numbers | 109003, 109004 |
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
Reason for recall
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
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-2716-2026. 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.