Class 2 Device Recall LEGION(TM) HK FEMORAL ASSEMBLY

• Date Initiated by Firm: May 26, 2016
• Create Date: June 29, 2016
• Recall Status: Terminated on August 16, 2019
• Recall Number: Z-2095-2016
• Recall Event ID: 74271
• 510(K)Number: K081111
• Product Classification: Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
• Product: LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365; ; The LEGION Hinge Knee System is indicated for:; 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery.; The LEGION Hinge Knee System is for cemented use only.
• Code Information: Lot codes: 15JM04561,15JM04570,15JM04589,15KM08936,15KM08937,15KM08940,15KM08942,15KM08948,15KM08949,15KM09010,15KM09011,15KM09013,15KM09014,15KM09015,15KM09016,15LM09119,15LM09122,15LM09123,15LM09124,15LM12483,15LM12484,15LM12486,15LM12488,15LM15652,15MM09829,15MM09833,16AM12222,16AM12224,16AM12235,16AM12237,16AM12240,16AM12243,16AM12255,16AM12268
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 1450 E Brooks Rd; Memphis TN 38116-1804
• For Additional Information Contact: Joe Metzger; 978-749-1330
• Manufacturer Reason for Recall: The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
• FDA Determined Cause: Process control
• Action: The firm sent an Urgent Product Recall letter dated May 26, 2016 to customers, via email and FedEx Overnight delivery . The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. Inspect inventory and locate any unused devices from the listed product and batch numbers, and quarantine them immediately. 2. Complete the Inventory Return Certification Form on the following page, indicating the quantities that need to be returned. If you do not have product to return, place an x in the column No Product to Return. Include your contact information in the spaces provided at the bottom of the form. 3. Contact Smith & Nephews Field Actions Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to return the completed Inventory Return Certification Form and obtain a return authorization (RA) number if you have product to return. 4. Return any affected product to the address listed on the Inventory Return Certification Form. Indicate the RA number on your return shipment.
• Quantity in Commerce: 97 units
• Distribution: Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.
• 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 = KRO and Original Applicant = SMITH & NEPHEW, INC.