ConforMIS, Inc. recalls ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPL…
- Recall date
- August 31, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0144-2016
- 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 Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111
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