Class 2 Device Recall EvolisFemoral Sizer Posterior Reference

• Date Initiated by Firm: September 11, 2009
• Create Date: June 26, 2015
• Recall Status: Terminated on February 29, 2012
• Recall Number: Z-2095-2010
• Recall Event ID: 55465
• 510(K)Number: K081023
• Product Classification: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: Evolis-Femoral Sizer Posterior Reference; ; The femoral sizer posterior reference is a manual orthopedic surgical instrument that is used to determine the trial size and set the external rotation. The femoral sizer is an alternate instrument that can be used in addition to the standard MIS femoral sizer.; ; The Femoral Sizer Posterior Reference intended to be placed on the distal femoral cut and determine the trail size and set the external rotation in preparation for the cut blocks. The femoral sizer posterior reference is intended to be placed on the distal femoral cut and determine the trial size and set the external rotation in preparation for the cut blocks. Indications for Use for the Medacta Evolis Total Knee System are: The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: - Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis - Avascular necrosis of femoral condyle - Post traumatic loss of joint configuration - Primary implantation failure.
• Code Information: Model Number: 02.07.10.0215
• Recalling Firm/ Manufacturer: Medacta Usa Inc; 4725 Calle Quetzal Unit B; Camarillo CA 93012-9101
• For Additional Information Contact: 858-705-0350
• Manufacturer Reason for Recall: Medacta USA Inc is initiating a recall on the Femoral Sizer, an orthopedic manual surgical instrument, because the "L" and "R" markings are mislabeled which would cause incorrect usage.
• FDA Determined Cause: Process design
• Action: The firm, Medacta USA Inc, sent an "Urgent Safety Notification" letter dated August 5, 2009, to the customers. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to check their inventory for devices listed, if found, to immediately sequester them and DO NOT use them in surgery. The customers were ask to please pack the affected femoral sizer(s) posterior reference for shipment to Medacta USA. Medacta informed the customers that Medacta USA personnel will contact them by telephone to provide them with an RMA number and the reworked femoral sizer(s) posterior reference will be returned as soon as they are available. If you have any questions, please feel free to contact the Medacta USA office at 805-437-7085 or contact Ms. Heather Neely directly at 805-886-1069.
• Quantity in Commerce: 5
• Distribution: Worldwide distribution: USA including states of Texas and Idaho and country of France.
• 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 = MEDACTA INTERNATIONAL, SA