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U.S. Department of Health and Human Services

Class 2 Device Recall LCS Complete Knee Revision System VVC Insert

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 Class 2 Device Recall LCS Complete Knee Revision System VVC Insertsee related information
Date Initiated by FirmNovember 08, 2016
Date PostedDecember 03, 2016
Recall Status1 Terminated 3 on June 05, 2017
Recall NumberZ-0703-2017
Recall Event ID 75608
PMA NumberP830055 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing - Product Code NJL
ProductLCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
Code Information LCS COMP VVC INS SM 22.5MM, Product Code: 129424122, Lot# C08294, GTIN: (01)10603295024484, Expiry: 31-Mar-2021
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information ContactTai L. Holmes-Johnson
574-371-4577
Manufacturer Reason
for Recall		DePuy Orthopaedics, Inc. is voluntarily recalling one lot of the LCS Complete Knee Revision System VVC Insert Small 22.5mm, due to the insert being manufactured outside of specifications, which prevents the insert from properly seating in the mating tibial tray.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionDePuy Orthopaedics, Inc. initiated a voluntary recall on 11/8/2016 via letter mailed to the customer. Only one device was distributed in the U.S., and this was removed from the hospital on 21-Oct-2016. This recall does not affect any other lots of the LCS Complete Knee Revision System VVC Insert Small 22.5mm devices. The recall notice provides instructions for notifying the medical facility that received, used, or purchased the affected lot of the LCS Complete Knee Revision System VVC Insert Small 22.5mm. The purpose of this device recall is to notify medical professionals of the possible effects of using the affected device and to communicate that there are no recalled devices distributed at this time. The customer was asked to do the following: Complete the Reconciliation Form and return to your DePuy Orthopaedics Sales Consultant or fax to 574-371-4939 or email to DPYUS-JointReconFieldActions@its.jnj.com within five (5) business-days of this notice. " Retain a copy of the completed Reconciliation Form and this notice in your files. " Forward this notice to others in your facility that need to be informed. Effectiveness will be determined by the return of one US Medical Facility Reconciliation Form. For questions about device recall information provided, please contact Kim Earle, Senior Recall Coordinator, at 574-371-4917 or kearle@its.jnj.com or DPYUS-JointReconFieldActions@its.jnj.com.
Quantity in Commerce1
DistributionUS Distribution in the state of TN
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = NJL
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