FDA recall Z-0663-2018

Product

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

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

Key facts

Status

Terminated

Initiation date

2017-07-24

Report date

2018-02-28

Termination date

2018-04-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Shannon, N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0663-2018