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U.S. Department of Health and Human Services

Class 2 Device Recall JOURNEY II BCS

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  Class 2 Device Recall JOURNEY II BCS see related information
Date Initiated by Firm September 27, 2023
Date Posted October 24, 2023
Recall Status1 Open3, Classified
Recall Number Z-0158-2024
Recall Event ID 93156
510(K)Number K140555  K111711  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
Code Information UDI/DI 00885556176467, Batch Number 22BM17564
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact David Snyder
978-749-1440
Manufacturer Reason
for Recall		 The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
FDA Determined
Cause 2		 Component change control
Action Smith & Nephew, Inc. issued an Urgent Medical Device Recall Notice to its consignees on 09/27/2023 via email and overnight mail. The notice explain the issue, potential risk, and requested the following actions: Inspect inventory, locate, and quarantine the affected devices. Sales representatives, district offices, or distributors were directed to notify their customers The firm is seeking return of unused products.
Quantity in Commerce 29 units
Distribution Worldwide distribution - US Nationwide and the country of Japan.
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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