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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy Orthopaedics LCS COMPLETE RPS

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  Class 2 Device Recall DePuy Orthopaedics LCS COMPLETE RPS see related information
Date Initiated by Firm March 04, 2015
Date Posted May 26, 2015
Recall Status1 Terminated 3 on October 30, 2015
Recall Number Z-1672-2015
Recall Event ID 71085
PMA Number P830055 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing - Product Code NJL
Product LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
Code Information All Lots. Catalog numbers: 129411010 129411020 129411030 129411040 129411050 129411060 129411070 129412010 129412020 129412030 129412040 129412050 129412060 129412070 129495040 129495050 129495060 129496040 129496050 129496060 
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Kimberly C. Earle
574-371-4917
Manufacturer Reason
for Recall		 The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS COMPLETE RPS Knee System is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action On 3/4/2015, URGENT INFORMATION - DEVICE CORRECTION NOTICE for the LCS COMPLETE RPS Knee System and on 3/19/2015 REVISED URGENT INFORMATION - DEVICE CORRECTION NOTICE for the LCS COMPLETE RPS Knee System (Revised) notifications were sent to the affected distributors and medical professionals. All distributors were notified via electronic mail, and all medical professionals with affected inventory were also notified by distributor or Sales Consultant via in person delivery or mail or electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. to 5 p.m. EDT).
Quantity in Commerce 19,059
Distribution Worldwide Distribution-US (nationwide) and the countries of CANADA, AUSTRALIA, AUSTRIA, BELGIUM, UK, FRANCE, GREECE, IRELAND, ISRAEL, ITALY, KOREA, LUXEMBOURG, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, SOUTH AFRICA, SWITZERLAND, THAILAND.
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.
PMA Database PMAs with Product Code = NJL and Original Applicant = DEPUY, INC.
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