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U.S. Department of Health and Human Services

Class 3 Device Recall ORTHO DEVELOPMENT BALANCED KNEE SYSTEM

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 Class 3 Recall
ORTHO DEVELOPMENT BALANCED KNEE SYSTEM
see related information
Date Posted September 09, 2009
Recall Status1 Terminated on May 11, 2010
Recall Number Z-1993-2009
Recall Event ID 52423
Premarket Notification
510(K) Number
K994370 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300, Ortho Development, Draper, Utah 84020. The Balanced Knee System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral stability.
Code Information Lot Number 0054891.
Recalling Firm/
Manufacturer
Ortho Development Corporation
12187 South Business Park Dr
Draper, Utah 84020
Manufacturer Reason
for Recall
Erroneous lot number on 3 of 28 units of Balanced Knee System. Three units from Lot Number 0055245 were mixed in with the recalled lot (0054891).
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Consignees were notified via e-mail on May 29, 2009 and June 5, 2009 requesting return of units. Direct questions about the recall to the Ortho Development Corporation by calling 1-801-619-3450.
Quantity in Commerce 13 units
Distribution Worldwide -- US (states of FL and TX) and Japan.
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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