FDA-Device2018-02-28Class II
NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
ZIMMER ORTHOPEDIC MFG LTD
Hazard
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.
Sold states
Worldwide Distribution - US Distribution to the states of : CA, MA, ME, MI, MN and WI., and to the countries of Germany, France and Italy.
Affected count
7 devices
Manufactured in
Building No 2 East Park, Shannon Industrial Estate, Shannon, N/A, Ireland
Products
NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0663-2018Don't want to check this manually?
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