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U.S. Department of Health and Human Services

Class 1 Device Recall LPS Diaphyseal Sleeves

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 Class 1 Recall
LPS Diaphyseal Sleeves
see related information
Date Posted February 15, 2013
Recall Status1 Terminated on May 20, 2014
Recall Number Z-0828-2013
Recall Event ID 63783
Premarket Notification
510(K) Number
K071417 
Product Classification Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer - Product Code MBH
Product LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
Code Information Part number: 198720018 and Lot numbers: 123506, 123507, 156208, 188414, 202951, 212351, B34GC1000, B4EGN1000, B4SBM1000, B5SHY1000, DH8F91000, DH8F9A000, DH8F9B000, DH8F9C, and FE5LL1.
Recalling Firm/
Manufacturer
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw, Indiana 46582-3994
For Additional Information Contact Mindy Tinsley
574-267-8143
Manufacturer Reason
for Recall
DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.
FDA Determined
Cause 2
DESIGN: Device Design
Action DePuy Othopaedics sent an Urgent Information Medical Device Recall Notice letter dated January 4, 2013 to all affected customers. The letter identified the affected products, reason for recall, clinical implications and actions to be taken. The letter instructed customers to check inventory, discontinue use, cease further distribution and return all inventory on hand for credit. Customers were requested to complete and return the Reconciliation Form. For product-related questions contact your local DePuy Othopaedics Sales Representative, clinical questions contact DePuy's Scientific Information Office at 1-888-554-2482 and recall notice information call 574-372-7333.
Quantity in Commerce 162 total units (US) and 102 units total (OUS)
Distribution Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, GA, ID, IL, MA, MD, MI, MN, NC, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV and the countries of Holland, Australia, Austria, South Africa and Canada including Veteran Administration hospitals.
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 = MBH and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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