FDA Device

UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26004 Femoral Component Size 4, 26006 Femoral Component Size 6, 26008 Femoral Component Size 8 and 26010 Femoral Component Size 10

Hazard

There exists the possibility that incomplete bony support or insufficient cementing of the implanted device can result in fatigue fracture of the UC-PLUS Solution Femoral Component.

What You Should Do

Remedy

The depth of the withdrawal action taken in June, 2003 was to the distributor (agent) level. Plus USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA.

Products

UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26004 Femoral Component Size 4, 26006 Femoral Component Size 6, 26008 Femoral Component Size 8 and 26010 Femoral Component Size 10
Brand
Plus Orthopedics USA
UPC
Lot Number: All lots considered affected Serial Number: None

Units Affected

68