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U.S. Department of Health and Human Services

Class 2 Device Recall SCORPIO NRG KNEE SYSTEM

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 Class 2 Recall
SCORPIO NRG KNEE SYSTEM
see related information
Date Posted December 01, 2009
Recall Status1 Terminated on April 05, 2010
Recall Number Z-0477-2010
Recall Event ID 53588
Premarket Notification
510(K) Number
K030978 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Scorpio NRG Posterior Stabilized Femoral, #9 left; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert.
Code Information Catalog Number 81-4409L, Lot code MHHK14.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
For Additional Information Contact Rita Intorella
201-972-2100
Manufacturer Reason
for Recall
It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barrier system.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action An "Urgent Product Recall" letter was sent on October 2, 2009 by Federal Express to Stryker branches and Hospital Risk Management Departments in the United States as well as foreign consignees. The letter described the issue, potential hazard and actions for affected accounts. Consignees were instructed to examine their inventory and return recalled product as instructed in the notification letter to Stryker Orthopaedics. In addition, consignees were instructed to reconcile affected product by completing the attached Product Accountability form (with spreadsheet) and faxing to 1-201-831-6069. Direct questions to Stryker Orthopaedics by calling 1-201-972-2100.
Quantity in Commerce 77 of total product
Distribution Worldwide Distribution -- United States (MA, NJ, IN, MI, CA and PA), Hong Kong, Germany, Netherlands, Japan, Korea, Switzerland, Malaysia, and the United Kingdom.
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 = HOWMEDICA OSTEONICS CORP.
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