ConforMIS, Inc. recalls Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
- Recall date
- January 28, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1070-2016
- FDA classification
- Class II
- Brand / firm
- ConforMIS, Inc.
- Sold / distributed
- KY
Why it was recalled
Incorrect femoral component distributed
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 Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
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