Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 2, sterile; Part number 1498-24-002.
FDA Recall Z-0458-2007 · Posted 2007-01-11
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Recalling FirmDepuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeHRY
Date Initiated2006-11-15
Date Terminated2008-04-30
Product Quantity558 for Recalls Z-0456-0465-2007
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Class II Recall - Worldwide Distribution ---USA and countries of Argentina and Colombia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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