FDA Medical Device Recalls (openFDA)
Depuy Orthopaedics, Inc.: Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 3, sterile; Part number 1498-24-003.
- Recall number
- Z-0460-2007
- Recalling firm
- Depuy Orthopaedics, Inc.
- Product
- Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 3, sterile; Part number 1498-24-003.
- Status
- Terminated
- Initiated
- 2006-11-15
- Posted
- 2007-01-11
- Terminated
- 2008-04-30
- 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.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K040268"]
- PMA numbers
- not on file
- Product code
- HRY
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28