Conformis iTotal Cruciate Retaining — Class II medical device recall Z-1070-2016
Terminated recall by ConforMIS, Inc., reported 2016-03-16, distributed in KY. Incorrect femoral component distributed
| Recall number | Z-1070-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConforMIS, Inc., Bedford, MA, United States |
| Recall initiated | 2016-01-28 |
| Classified | 2016-03-08 |
| Reported by FDA | 2016-03-16 |
| Terminated | 2016-03-09 |
| Distributed | KY |
| Quantity | 1 units |
| Serial numbers | 0363410 |
| Model numbers | TCR-111-1111 |
Product
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
Reason for recall
Incorrect femoral component distributed
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-1070-2016. 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.