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U.S. Department of Health and Human Services

Class 2 Device Recall PSC Femoral Nonporous Rt Sz 6

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 Class 2 Recall
PSC Femoral Nonporous Rt Sz 6
see related information
Date Posted May 13, 2014
Recall Status1 Terminated on July 14, 2014
Recall Number Z-1610-2014
Recall Event ID 68029
Premarket Notification
510(K) Number
K994370 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
Code Information Lot No. A131876
Recalling Firm/
Manufacturer
Ortho Development Corporation
12187 Business Park Dr
Draper, Utah 84020-8663
For Additional Information Contact Mike Ensign
801-553-9991
Manufacturer Reason
for Recall
A femoral component containing pegs was found in a box for the pegless version.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Ortho notified customers via email and phone calls on April 1, 2014. Customers were asked to return product in inventory.
Quantity in Commerce 5
Distribution US Nationwide Distribution in the states of NV, and AZ.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ORTHO DEVELOPMENT CORP.
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