Class 2 Device Recall LEGION(R) CR XLPE HIGH LEXION Articular Insert

• Date Initiated by Firm: March 30, 2018
• Create Date: May 22, 2018
• Recall Status: Terminated on August 21, 2019
• Recall Number: Z-1904-2018
• Recall Event ID: 79875
• 510(K)Number: K071071
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
• Code Information: Batch Number 16EM12620
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 1450 E Brooks Rd; Memphis TN 38116-1804
• For Additional Information Contact: 901-396-2121
• Manufacturer Reason for Recall: The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
• FDA Determined Cause: Packaging process control
• Action: The firm initiated the recall by letter on 03/30/2018. The consignee was direct to return any recalled devices.
• Quantity in Commerce: 16 units
• Distribution: US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
• 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