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U.S. Department of Health and Human Services

Class 2 Device Recall P.F.C. SIGMA Revision Knee System Distal Augment

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  Class 2 Device Recall P.F.C. SIGMA Revision Knee System Distal Augment see related information
Date Initiated by Firm July 18, 2018
Create Date August 29, 2018
Recall Status1 Terminated 3 on April 17, 2019
Recall Number Z-2949-2018
Recall Event ID 80666
510(K)Number K952830  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
Code Information Lot: C2KJ24, GTIN: 10603295234135
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Mindy K. Tinsley
574-372-7136
Manufacturer Reason
for Recall		 This unit may be missing the screw/collet Assembly
FDA Determined
Cause 2		 Employee error
Action The notification letter distributed in July 2018 instructed the customer to perform the following actions: " Please cease using the affected device immediately. " Medical facility to return affected implant immediately to their Sales Consultant. " Review this notice and complete the Acknowledgement section (Attachment A) to signify that your facility has been informed of this recall. Return the completed Acknowledgement to your Sales Consultant within five (5) working days of this notice. " Retain a copy of the completed Acknowledgement Form in your files along with this notice. " Notify surgeons at your facility by providing them with a copy of this notice to ensure surgeons are aware of this recall. " Share this notice with others in your facility who need to be informed.
Quantity in Commerce 1
Distribution The devices were not distributed in the United States. The devices were distributed to the following foreign countries: Great Britain.
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 = JWH and Original Applicant = JOHNSON & JOHNSON PROFESSIONALS, INC.
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