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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 6see related information
Date Initiated by FirmApril 01, 2014
Date PostedMay 13, 2014
Recall Status1 Terminated 3 on July 14, 2014
Recall NumberZ-1610-2014
Recall Event ID 68029
510(K)NumberK994370 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductPS-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 ContactMike 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
ActionOrtho notified customers via email and phone calls on April 1, 2014. Customers were asked to return product in inventory.
Quantity in Commerce5
DistributionUS Nationwide Distribution in the states of NV, and AZ.
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.
510(K) Database510(K)s with Product Code = JWH
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