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
FDA Recall Z-0191-2007 · Posted 2006-11-16
Recalling FirmPlus Orthopedics USA
Recall StatusTerminated
Product CodeHRY
Date Initiated2006-07-18
Date Terminated2007-12-13
Product Quantity68
Reason for Recall
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
California
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.