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U.S. Department of Health and Human Services

Class 2 Device Recall JOURNEY II UNI

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  Class 2 Device Recall JOURNEY II UNI see related information
Date Initiated by Firm March 27, 2023
Date Posted April 14, 2023
Recall Status1 Open3, Classified
Recall Number Z-1393-2023
Recall Event ID 91974
510(K)Number K190085  
Product Classification Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
Code Information Catalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R
Recalling Firm/
Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact David Snyder
Manufacturer Reason
for Recall
A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.
FDA Determined
Cause 2
Under Investigation by firm
Action Smith & Nephew notified consignees via email and overnight mail on 03/27/2023. Consignees were instructed to immediately review inventory and quarantine any affected units, notify customers if the product was further distributed, complete and return the response form and arrange for the return of affected units.
Quantity in Commerce 12 units
Distribution US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.
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 = HSX and Original Applicant = Smith & Nephew Inc