Recall Z-1742-2011 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Ortho Development Corporation
UC Tibial Insert, Size 4, 12mm, REF 163-3412, Sterile R, Ortho Development, Draper, Utah 84020 The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base for the metal femoral portion of the system, and moderates the degree of flexion afforded by the procedure.
| Date | Jan 7, 2011 |
| Status | Terminated |
| Reason | Components of a replacement knee system could be mislabeled. |
| Root cause | Error in labeling |
| Action | The firm, Ortho Development, sent a "Field Notification Memo" date January 7, 2011 to its customers. The memo described the product, problem and action to be taken. The customers were instructed to promptly return any remaining parts of the listed product; locate all the parts in their inventory; identify any of the listed parts that may have been used in surgery; verify the quantity they have on hand and the quantity used in surgery and reconcile them with the quantity sent; if discrepancy exists, notify customer service resolution; prepare items for return and contact customer service to obt |
| Quantity | 33 units (US) |
| Distribution | Worldwide distribution: USA including states of: AZ, CA, FL, MI, TX, and UT; and country of: Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060569 | BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM Ortho Development Corp., Jul 6, 2006 |