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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 Insertssee related information
Date Initiated by FirmDecember 19, 2019
Create DateMarch 17, 2020
Recall Status1 Terminated 3 on September 04, 2024
Recall NumberZ-1507-2020
Recall Event ID 84647
510(K)NumberK071071 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductLEGION PS High Flex XLPE size 5-6 9mm Articular Insert
Code Information Lot Number 19FM12500; Product Number 71453221.
FEI Number 1020279
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information ContactDavid 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
ActionThe 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 Commerce29 units
DistributionUSA: 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 CycleTPLC 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) Database510(K)s with Product Code = JWH
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