—#49635

Product

Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 5, sterile; Part number 1498-24-005.

FDA product code: HRY — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K040268
Affected lot / code info: All lots.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Depuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Class II Recall - Worldwide Distribution ---USA and countries of Argentina and Colombia.

Timeline

Recall initiated: 2006-11-15
Posted by FDA: 2007-01-11
Terminated: 2008-04-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49635. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.