Recall Z-0463-2007 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Depuy Orthopaedics, Inc.
Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Right Medial/Left Lateral, Size 4, sterile; Part number 1498-23-004
| Date | Jan 11, 2007 (initiated Nov 15, 2006) |
| Status | Terminated |
| Reason | Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect. |
| Root cause | Other |
| Action | The firm's sales force was notified of the recall via email sent 11/15/06. The sales force was instructed to deliver a recall letter to personnel in those facilities that had purchased the products, and the recall letters instruct the facilities to quarantine the product and respond to Depuy concerning product returns. The sales force was provided with a Dear Doctor letter for issuance to implanting surgeons at the sales forces' discretion. The recall was extended to Sizes 1-5 on Dec 5, 2006 with a second recall letter. |
| Quantity | 558 for Recalls Z-0456-0465-2007 |
| Distribution | Class II Recall - Worldwide Distribution ---USA and countries of Argentina and Colombia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040268 | DEPUY PRESERVATION UNICONDYLAR TIBIA DePuy Orthopaedics, Inc., May 5, 2004 |