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U.S. Department of Health and Human Services

Class 2 Device Recall LEGION High Flex PS Inserts

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  Class 2 Device Recall LEGION High Flex PS Inserts see related information
Date Initiated by Firm December 19, 2019
Create Date March 17, 2020
Recall Status1 Completed
Recall Number Z-1507-2020
Recall Event ID 84647
510(K)Number K071071  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
Code Information Lot Number 19FM12500; Product Number 71453221.
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact David Snyder
978-749-1440
Manufacturer Reason
for Recall		 LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
FDA Determined
Cause 2		 Process control
Action The firm initiated the recall by letter on January 6, 2020. The letter identified the problem and directed the consignee to quarantine the devices. The notice instructs to complete and return the response form and to make arrangement for the return of affected product. For any questions or concerns please contact: FieldActions@smith-nephew.com.
Quantity in Commerce 29 units
Distribution USA: TN, NC, CA,OR, NM, TX, PA, MI, LA, DA, IL. Int'l: IT (Italy), NL (Netherlands), RO (Romania), PR (Puerto Rico).
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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = SMITH & NEPHEW, INC.
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