Medical device recalls Moderate risk

ZIMMER ORTHOPEDIC MFG LTD recalls NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthr…

Recall date
July 24, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0663-2018
FDA classification
Class II
Brand / firm
ZIMMER ORTHOPEDIC MFG LTD
Sold / distributed
Worldwide Distribution - US Distribution to the states of : CA, MA, ME, MI, MN and WI., and to the countries of Germany, France and Italy.

Why it was recalled

There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.

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