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U.S. Department of Health and Human Services

Class 2 Device Recall smith & Nephew Legion

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 Class 2 Device Recall smith & Nephew Legionsee related information
Date Initiated by FirmOctober 02, 2024
Date PostedOctober 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0278-2025
Recall Event ID 95493
510(K)NumberK043440 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Productsmith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Code Information UDI/DI 03596010543837, Batch Number 23LM03388
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
6409 E Holmes Rd
Memphis TN 38141-8310
For Additional Information ContactDavid Snyder
978-749-1440
Manufacturer Reason
for Recall		Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
FDA Determined
Cause 2		Packaging change control
ActionSmith & Nephew issued an "Urgent Medical Device Recall Notice" to its consignees on 10/02/2024 via email. The notice explained the issue, potential risk of use of the affected product, and requested the return of the affected devices. Distributors, sales reps, and district offices were directed to notify their customers. If you have any questions or concerns regarding this recall please contact FieldActions@smith nephew.com.
Quantity in Commerce2 units
DistributionUS Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JWH
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