Recall Z-1993-2009 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Ortho Development Corporation
Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300, Ortho Development, Draper, Utah 84020. The Balanced Knee System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral stability
| Date | Sep 9, 2009 (initiated May 29, 2009) |
| Status | Terminated |
| Reason | Erroneous lot number on 3 of 28 units of Balanced Knee System. Three units from Lot Number 0055245 were mixed in with the recalled lot (0054891). |
| Root cause | Mixed-up of materials/components |
| Action | Consignees were notified via e-mail on May 29, 2009 and June 5, 2009 requesting return of units. Direct questions about the recall to the Ortho Development Corporation by calling 1-801-619-3450. |
| Quantity | 13 units |
| Distribution | Worldwide -- US (states of FL and TX) and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994370 | ORTHO DEVELOPMENT BALANCED KNEE SYSTEM Ortho Development Corp., Mar 24, 2000 |