Recall Z-0192-2007 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Plus Orthopedics USA
UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10
| Date | Nov 16, 2006 (initiated Jul 18, 2006) |
| Status | Terminated |
| Reason | The modified devices were distributed by Plus Orthopedics USA (Plus USA) June 10, 2003 prior to FDA approval to market of the modified device (Special 510(k) K032052, clearance date July 25, 2003) and withdrawn from the field June 25, 2003. |
| 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 | 12 |
| Distribution | California |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032052 | UC-PLUS SOLUTION UNICONDYLAR KNEE Plus Orthopedics, Jul 25, 2003 |