Recall Z-0191-2007 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Plus Orthopedics USA
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
| Date | Nov 16, 2006 (initiated Jul 18, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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. |
| Quantity | 68 |
| Distribution | California |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982859 | UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM Plus Orthopedics, Jul 30, 1999 |