• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall LEGION(R) CR XLPE HIGH LEXION Articular Insert see related information
Date Initiated by Firm March 30, 2018
Create Date May 22, 2018
Recall Status1 Terminated 3 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/
Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact
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 2
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 and Original Applicant = SMITH & NEPHEW, INC.