ConForMIS iTotal CR — Class II medical device recall Z-0145-2016
Terminated recall by ConforMIS, Inc., reported 2015-10-28, distributed nationwide. May contain small amounts of ethylene glycol residue
| Recall number | Z-0145-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConforMIS, Inc., Bedford, MA, United States |
| Recall initiated | 2015-08-31 |
| Classified | 2015-10-21 |
| Reported by FDA | 2015-10-28 |
| Terminated | 2016-03-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, DE, GB |
| Quantity | 313 units |
| Reason classes | chemical contamination |
| Serial numbers | 0336962, 0347736, 0347842, 0348392, 0348488, 0348897, 0348956, 0349020, 0349138, 0349619, 0349828, 0350255, 0350639, 0350752, 0350960, 0351033, 0351048, 0351118, 0351132, 0351187, 0351297, 0351478, 0351546, 0351800, 0351811 and 288 more |
| Model numbers | M57250600010 |
Product
ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)
Reason for recall
May contain small amounts of ethylene glycol residue
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-0145-2016. 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.