FDA Device

PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.

Hazard

A femoral component containing pegs was found in a box for the pegless version.

What You Should Do

Remedy

Ortho notified customers via email and phone calls on April 1, 2014. Customers were asked to return product in inventory.

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Products

PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
Brand
Ortho Development Corporation
UPC
Lot No. A131876

Units Affected

5

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