Class 2 Device Recall SCORPIO NRG KNEE SYSTEM

• Date Initiated by Firm: October 02, 2009
• Date Posted: December 01, 2009
• Recall Status: Terminated on April 05, 2010
• Recall Number: Z-0476-2010
• Recall Event ID: 53588
• 510(K)Number: K030978
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: Scorpio NRG Posterior Stabilized Femoral, # 7 left/right;; 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 81-4407L, lot code MHHEY8 and Catalog number 81-4407R, lot codes: MHHAEV and MHHM4K.
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah NJ 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: Other
• 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 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 = HOWMEDICA OSTEONICS CORP.