Z-0663-2018 Class II Terminated

Recalled by ZIMMER ORTHOPEDIC MFG LTD — Shannon, N/A

Recall Details

Product Type
Devices
Report Date
February 28, 2018
Initiation Date
July 24, 2017
Termination Date
April 16, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7 devices

Product Description

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

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution - US Distribution to the states of : CA, MA, ME, MI, MN and WI., and to the countries of Germany, France and Italy.

Code Information

Item Number: 00-5964-017-51, Lot Numbers (UDI Number): 63329529 ((01) 00889024001152 (17) 260430 (10) 63329529); 63342472 ((01) 00889024001152 (17) 260430 (10) 63342472); 63329533 ((01) 00889024001152 (17) 260430 (10) 63329533); 63329527 ((01) 00889024001152 (17) 260430 (10) 63329527)