JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
Summary
The FDA issued a Class II for JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthe by Smith & Nephew, Inc.. Reason: 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 .
Details
Source
Device Recall
External ID
Z-0157-2024
Action Date
2023-11-01
Status
Ongoing
Category
device
Product Description
JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
Lot/Code Info: UDI/DI 00885556178010, Batch Number 22BM18348
Quantity Affected: 28 units
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.
Distribution
Worldwide distribution - US Nationwide and the country of Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-27
Company
Memphis, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Smith & Nephew, Inc. has 78 FDA actions in our database, including 34 recalls and 44 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Smith & Nephew, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Smith & Nephew, Inc. have FDA actions?
Smith & Nephew, Inc. has 78 FDA actions in our database, including 34 recalls and 44 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0157-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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