Summary
The FDA issued a Class II for JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM by Smith & Nephew, Inc.. Reason: A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM ins.
Details
Source
Device Recall
External ID
Z-1393-2023
Action Date
2023-04-26
Status
Ongoing
Category
device
Product Description
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Lot/Code Info: Catalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R
Quantity Affected: 12 units
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.
Distribution
US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-27
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 134 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-1393-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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