ConforMIS, Inc. recalls ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US)…
- Recall date
- August 31, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0145-2016
- FDA classification
- Class II
- Brand / firm
- ConforMIS, Inc.
- Sold / distributed
- Distributed Nationwide and in Germany, Switzerland, and UK.
Why it was recalled
May contain small amounts of ethylene glycol residue
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)
Get recall alerts
Free email alert whenever ConforMIS, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: ConforMIS, Inc.