Conformis iTotal CR G2 Knee Replacement System Catalog/Model #:… — Class II medical device recall Z-0581-2015
Terminated recall by ConforMIS, Inc., reported 2014-12-17. Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
| Recall number | Z-0581-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConforMIS, Inc., Bedford, MA, United States |
| Recall initiated | 2014-11-19 |
| Classified | 2014-12-10 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2015-10-08 |
| Quantity | 1 units |
| Serial numbers | 0340552 |
| Model numbers | M57250600010 |
Product
Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.
Reason for recall
Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
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-0581-2015. 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.