Z-0464-2007

Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 5...

Name: Z-0464-2007 Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 5...
Creator: Depuy Orthopaedics, Inc.
Published: 2006-11-15
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2006-11-15 / Terminated / root cause: packaging

FDA source

Depuy Orthopaedics, Inc. began a recall of Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 5, sterile; Part number 1498-24-005 on 2006-11-15. The reason FDA records is "Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0464-2007
Status: Terminated
Initiated: 2006-11-15
Posted: 2007-01-11
Terminated: 2008-04-30
Recalling firm: Depuy Orthopaedics Inc.
Product: Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 5, sterile; Part number 1498-24-005.
Product code: HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
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.
Root cause tag: packaging
FDA 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 in commerce: 558 for Recalls Z-0456-0465-2007
Distribution: Class II Recall - Worldwide Distribution ---USA and countries of Argentina and Colombia.
Product codes and lots: All lots.

Product code HRY

K040268Class IIDepuy Preservation Unicondylar TibiaDePuy Orthopaedics, Inc. / cleared 2004-05-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)