Medical device recalls Moderate risk

ConforMIS, Inc. recalls ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230

Recall date
August 31, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0142-2016
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 iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230

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