Recall Z-1610-2014 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Ortho Development Corporation
PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
| Date | May 13, 2014 (initiated Apr 1, 2014) |
| Status | Terminated |
| Reason | A femoral component containing pegs was found in a box for the pegless version. |
| Root cause | Process control |
| Action | Ortho notified customers via email and phone calls on April 1, 2014. Customers were asked to return product in inventory. |
| Quantity | 5 |
| Distribution | US Nationwide Distribution in the states of NV, and AZ. |
| 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 |