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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 UNIsee related information
Date Initiated by FirmMarch 27, 2023
Date PostedApril 14, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1393-2023
Recall Event ID 91974
510(K)NumberK190085 
Product Classification Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
ProductJOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Code Information Catalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R
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		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
ActionSmith & 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 Commerce12 units
DistributionUS Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.
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 = HSX
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