Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 5, sterile; Part
FDA device recall Z-0464-2007 · posted 2007-01-11 · Terminated
Recall details
- Recalling firm
- Depuy Orthopaedics, Inc.
- Reason for recall
- Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HRY
- Quantity affected
- 558 for Recalls Z-0456-0465-2007
- Distribution
- Class II Recall - Worldwide Distribution ---USA and countries of Argentina and Colombia.
- Date initiated
- 2006-11-15
- Date posted
- 2007-01-11
- Date terminated
- 2008-04-30
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DEPUY PRESERVATION UNICONDYLAR TIBIA (K040268) | DePuy Orthopaedics, Inc. | 2004-05-05 |