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Recall Observatory FDA recall evidence

Device product

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

Z-0663-2018

July 24, 2017

Class II

Product summary

Firm
ZIMMER ORTHOPEDIC MFG LTD
Event
Event 78960
Status
Terminated
Classification
Class II
Quantity
7 devices
Official record key
device-enforcement:Z-0663-2018

Official wording

Reason: 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.

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)

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.