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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 Device Recall PSC Femoral Nonporous Rt Sz 6 see related information
Date Initiated by Firm April 01, 2014
Date Posted May 13, 2014
Recall Status1 Terminated 3 on July 14, 2014
Recall Number Z-1610-2014
Recall Event ID 68029
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 UT 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		 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 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 = ORTHO DEVELOPMENT CORP.
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