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U.S. Department of Health and Human Services

Class 2 Device Recall Depuy Preservation UniCompartmental Knee

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  Class 2 Device Recall Depuy Preservation UniCompartmental Knee see related information
Date Initiated by Firm November 15, 2006
Date Posted January 11, 2007
Recall Status1 Terminated 3 on April 30, 2008
Recall Number Z-0461-2007
Recall Event ID 36849
510(K)Number K040268  
Product Classification Tibial Tray - Product Code HRY
Product Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Right Medial/Left Lateral, Size 3, sterile; Part number 1498-23-003.
Code Information All lots.
Recalling Firm/
Manufacturer		 Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact
800-366-8143
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRY and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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