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U.S. Department of Health and Human Services

Class 2 Device Recall ATTUNE Revision CRS Femoral RT SZ 5 Cemented

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  Class 2 Device Recall ATTUNE Revision CRS Femoral RT SZ 5 Cemented see related information
Date Initiated by Firm April 16, 2018
Date Posted April 30, 2018
Recall Status1 Terminated 3 on April 02, 2019
Recall Number Z-1704-2018
Recall Event ID 79818
510(K)Number K160700  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
Code Information Lot Number HD6516, GTIN Number 10603295042280
Recalling Firm/
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Mindy K. Tinsley
Manufacturer Reason
for Recall
There may be burrs on the extraction hole threads.
FDA Determined
Cause 2
Process control
Action Notification letters distributed on 4/17/18 instructed customers to perform the following: Steps to Take Please take the following actions: " Immediately return unused affected units: Note: On March 19, 2018, one unit was removed from consignment. Two units were implanted prior to the medical device recall. No additional units are in the market. " Reconciliation Form: Complete the reconciliation form and return to your sales consultant or fax to 574-371-4939 or email to klong16@its.jnj.com within five (5) days of this notice. " Records: Retain a copy of the completed reconciliation form in your files along with this notice. " Additional Notifications: o Notify surgeons at your facility by providing them with a copy of this notice. Forward this notice to others in your facility that need to be informed. Clinical Implications and Patient Impact DePuy (Ireland) is not recommending prophylactic revision in the absence of symptoms. The company recommends that surgeons discuss potential clinical implications and risks with symptomatic patients that received the affected units.
Quantity in Commerce 1 unit
Distribution The products were distributed to the following US states: FL, MO, and PA.
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 = Depuy (Ireland)