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U.S. Department of Health and Human Services

Class 2 Device Recall smith&nephew LEGION OXINUM

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  Class 2 Device Recall smith&nephew LEGION OXINUM see related information
Date Initiated by Firm August 31, 2023
Date Posted September 20, 2023
Recall Status1 Open3, Classified
Recall Number Z-2621-2023
Recall Event ID 92976
510(K)Number K112941  K230653  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
Code Information UDI/DI: 00885556234006, Lot Number: 23EM09878
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
6409 E Holmes Rd
Memphis TN 38141-8310
For Additional Information Contact David Snyder
978-749-1440
Manufacturer Reason
for Recall		 The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.
FDA Determined
Cause 2		 Labeling Change Control
Action Smith & Nephew issued an Urgent Medical Device3 Recall Notice to its consignees on 08/31/2023 via letter and email. The notice explained the problem and potential risk and requested the consignee quarantine the affected product. Distributors were directed to notify their customers. Firm is seeking return of the affected product.
Quantity in Commerce 8 units
Distribution OH, CT, TX, NC, CA, NE, NV
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 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) Database 510(K)s with Product Code = JWH and Original Applicant = SMITH & NEPHEW, INC.
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