Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew Legion Oxinium

  • 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 Smith & Nephew Legion Oxiniumsee related information
Date Initiated by FirmOctober 02, 2024
Date PostedOctober 31, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0282-2025
Recall Event ID 95494
510(K)NumberK112941 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Productsmith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic
Code Information UDI/DI 00885556234204, Batch number 23LM02905
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 LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT 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. Return affected product to: Smith+Nephew | Attn: Quality Hold and Field Action Returns Department | 1450 E Brooks Road, Building G | Memphis, TN 38116 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 Commerce8 units
DistributionUS Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada
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
-
-